Adhese 2 Dental Amalgam Recall, Ivoclar Vivadent AG
ANSM issued safety alert R2609516 regarding a batch recall of Adhese 2 dental amalgam by Ivoclar Vivadent AG. Healthcare facilities, dental centers, and dental surgeons using this product should verify their inventory for affected lots. The company has directly notified impacted users with return instructions.
Vue PACS v12 Philips Medical Systems Safety Recall
ANSM reported a safety action by Philips Medical Systems Nederland BV regarding Vue PACS v12. Users have received direct notification from the manufacturer. The safety action is registered under reference R2607071.
Olympus Thunderbeat II Medical Device Recall
ANSM issued safety alert R2608456 regarding a lot withdrawal of Olympus Thunderbeat II ultrasonic and electric surgical scissors. Olympus notified the agency of a batch recall affecting interior use pharmacies and health establishments in France. Users received direct correspondence with recall instructions. The recall is registered under reference R2608456.
Joint Commission HHA Accreditation Renewal Request
CMS has published a proposed notice announcing receipt of the Joint Commission's application for continued recognition as a national accrediting organization for home health agencies (HHAs) seeking Medicare or Medicaid participation. The agency is soliciting public comments on this renewal request through May 4, 2026.
ACHC Hospice Accreditation Reapproved by CMS
CMS has approved the reapplication of the Accreditation Commission for Health Care Inc. (ACHC) for continued status as a national accrediting organization for hospice programs under Medicare and Medicaid. The approval term runs from November 27, 2025 through November 27, 2031, a standard six-year renewal period. ACHC-accredited hospices will continue to receive deemed status for Medicare participation without requiring separate state agency certification.
ACHC Critical Access Hospital Accreditation Approval
CMS announced continued approval of the Accreditation Commission for Health Care Inc. (ACHC) as a national accrediting organization for Critical Access Hospitals participating in Medicare or Medicaid. The approval period runs for six years, from December 27, 2025 through December 27, 2031.
Renewal of Poultry Slaughter Inspection Information Collection
FSIS is requesting renewal of its approved poultry slaughter inspection information collection (OMB No. 0583-0156) under the Paperwork Reduction Act of 1995. There are no changes to the information collection requirements. The current approval expires August 31, 2026. Comments on this renewal are due June 2, 2026.
Heart Pump Device Correction - Impella RP SmartAssist Sensor Drift
FDA identified a Class I recall of Abiomed Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps due to differential pressure sensor drift causing inaccurate pump flow readings on the Automated Impella Controller. The correction involves updated Instructions for Use requiring clinicians to reference P-level flow rate tables instead of AIC display values. Affected product codes: 0046-0035 and 1000323.
Abiomed Impella Heart Pump Purge Cassette Recall
The FDA issued a Class I recall notice for Abiomed's Generation 1 Impella Purge Cassettes and Impella RP Pump Sets due to an increased risk of purge leaks that may cause pump failure, resulting in patient death. Abiomed has reported four serious injuries and no deaths associated with this issue as of February 3, 2026. Healthcare facilities must immediately identify, quarantine, and return affected Generation 1 devices, transitioning to Generation 2 Purge Cassettes where available.
FDA Petition Attachment - Content Restricted
FDA received a petition (FDA-2026-P-3664) with restricted attachment content. The document appears to be a regulatory filing submitted to the agency. Specific substance and scope cannot be determined due to copyright restrictions on the attachment.
Background Material Supporting Proposed Regulatory Action
The FDA published background material supporting docket FDA-2026-P-3665. This document provides supplementary information related to a proposed regulatory action in the pharmaceutical or medical product space. The docket is open for public review and potential comment submission.
Patent Extension Comment Period
FDA has opened a 60-day public comment period for a patent extension matter under docket FDA-2025-E-3074-0006. The agency is seeking stakeholder input on the EMRELIS patent extension proposal. Interested parties may submit comments through Regulations.gov.
ENCELTO Regulatory Review Period Determination for Patent Extension
The FDA has determined the regulatory review period for ENCELTO, a human biological product, and published this notice as required by law for patent extension purposes. Any person may submit comments on the accuracy of the published dates by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.
INJECTAFER Regulatory Review Period for Patent Extension
FDA has determined the regulatory review period for INJECTAFER (ferric carboxymaltose injection) for purposes of patent extension under 35 U.S.C. 156. The Agency published this notice as required by law following a patent extension application submitted to the USPTO. Any person with knowledge of incorrect dates may submit comments by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.
FDA Survey Comment Form
The Food and Drug Administration (FDA) has opened a public comment period on a survey (Docket FDA-2026-N-2740-0001) via regulations.gov. The comment period remains open until June 2, 2026. This is a standard consultation seeking public input on an unspecified FDA survey topic.
ENFLONSIA Patent Extension Consultation
The FDA is seeking public comments on an ENFLONSIA patent extension application (Docket FDA-2025-E-3626-0006). Comments must be submitted by June 2, 2025 via Regulations.gov. This consultation follows standard FDA procedures for pharmaceutical patent-related matters.
FDA Acknowledgement of Submission from Hyman Phelps McNamara
FDA CDER issued an acknowledgement letter to Hyman, Phelps & McNamara, P.C. regarding a submission under docket FDA-2026-P-3664-0002. The acknowledgement confirms receipt of the submission but no substantive regulatory action is detailed in the available metadata.
EMRELIS Patent Extension Comment Form
FDA has opened a public comment period for EMRELIS patent extension matter via regulations.gov docket FDA-2025-E-3073. The 60-day comment window allows interested parties to submit feedback on the patent term extension application. Commenters may submit as individuals, organizations, or anonymously with attachments up to 10MB.
VYLOY Patent Extension Notice Comment
FDA is accepting public comments on a patent term extension notice for VYLOY (cisplatin), a chemotherapy drug. Comments are being submitted through Regulations.gov docket FDA-2025-E-0863. The notice relates to potential patent term extension eligibility under the Drug Price Competition and Patent Term Restoration Act.
VYLOY Patent Extension Comment Period Notice
The FDA has opened a 60-day public comment period for a patent extension application related to the drug VYLOY (zolbetuximab). Pharmaceutical companies and other interested parties may submit comments on the patent term restoration matter. The comment period provides an opportunity for stakeholders to voice concerns or support regarding the extension.
VYLOY Patent Extension Application Comment Period
FDA opened a 60-day public comment period on a patent term extension application for VYLOY, a drug product. Commenters may submit feedback through regulations.gov regarding this application.
ZIIHERA Patent Extension Comment Form
FDA has opened a public comment period on Regulations.gov for a patent extension related to ZIIHERA. The comment form is accessible for submission of feedback by interested parties including pharmaceutical companies, manufacturers, and individuals. The docket number is FDA-2025-E-0372-0005.
VYLOY Patent Extension Comment Period
FDA has opened a public comment period on a patent term extension application for VYLOY (citizens乏 details unspecified). Comments on FDA-2025-E-0866-0006 must be submitted by June 2, 2025. This consultation allows interested parties to provide input on the patent extension determination.
VYLOY Regulatory Review Period Patent Extension Comment Form
FDA opened a public comment period on the regulatory review period patent extension for VYLOY (vonoprazan), a potassium-competitive acid blocker approved for gastric acid-related conditions. Comments are being accepted through regulations.gov docket FDA-2025-E-0845. Stakeholders may submit comments on behalf of themselves, organizations, or anonymously.
Newsletter on Transplantation and Donation Practices
EDQM published a newsletter addressing transplantation and donation practices. The newsletter appears to be an informational communication for healthcare professionals and stakeholders involved in organ donation and transplantation across Europe. Specific content details were inaccessible at the time of this review.
Technetium Tc 99m Albumin Aggregated Injection Revision
USP's Small Molecules 4 Expert Committee has issued a Notice of Intent to Revise the Technetium Tc 99m Albumin Aggregated Injection monograph due to a compliance concern with the Appearance acceptance criterion. Comments with supporting data prompted this action. The proposed revision is targeted for an August 1, 2026 official date and is expected to be published as a Revision Bulletin on July 31, 2026.
UK and US deepen regulatory cooperation on medical devices
MHRA and FDA announced strengthened cooperation on medical device regulation to support faster access to safe, innovative technologies for patients in both countries. The regulators will explore mutual recognition mechanisms, reduce duplication for manufacturers, and streamline approval processes while maintaining independent safety standards. The UK MedTech sector employs over 195,000 people.
VYLOY Patent Extension Regulatory Review Period Determination
The Food and Drug Administration has determined the regulatory review period for VYLOY, a human biological product, for purposes of patent extension under federal law. The notice invites public comments on the accuracy of published dates by June 2, 2026, and allows interested persons to petition FDA regarding due diligence by September 30, 2026. This determination affects patent extension calculations for the branded drug manufacturer.
Determination of Regulatory Review Period for EMRELIS Patent Extension
FDA has determined the regulatory review period for EMRELIS, a human biological product, and published this determination as required by law. The notice allows interested parties to comment on the accuracy of dates and to petition FDA regarding due diligence during the review period.
Medical Device Variance Renewal - Redhouse Productions
FDA CDRH approved a variance renewal for Redhouse Productions (FDA-2023-V-2753-0004). The variance allows deviation from standard medical device manufacturing requirements under specific conditions. The renewal maintains previously granted flexibilities for the regulated entity.
Complaint Regarding Potential Regulatory Violation
FDA posted a complaint under docket FDA-2026-H-3081-0001 on April 3, 2026. The complaint, authored by CTP (Center for Tobacco Products), relates to a potential regulatory violation. No documents are currently available for review on regulations.gov.
ENFLONSIA Regulatory Review Period Determination
FDA has determined the regulatory review period for ENFLONSIA, a human biological product, as required by 35 U.S.C. 156 for patent extension purposes. The notice invites public comment on whether the published dates are incorrect and allows interested parties to petition FDA regarding the applicant's due diligence during the review period.
VYLOY Patent Extension Regulatory Review Period Determination
The FDA has determined the regulatory review period for VYLOY, a human biological product, and published this notice as required under 35 U.S.C. 156. The notice invites comments on whether any published dates are incorrect by June 2, 2026, and allows interested persons to petition FDA regarding due diligence by September 30, 2026.
Customer Service Satisfaction Surveys - PRA Comment Request
The FDA is seeking public comments on proposed customer service satisfaction surveys under the Paperwork Reduction Act of 1995. The 60-day comment period closes June 2, 2026. This is a routine information collection request; no new burdens are proposed as it involves existing customer service survey collections.
FDA determines regulatory review period for VYLOY patent extension
The Food and Drug Administration has determined the regulatory review period for VYLOY, a human biological product, and published this notice as required by 35 U.S.C. 156 for patent extension purposes. The determination is part of a batch of regulatory review period notices (dockets FDA-2025-E-0845 through FDA-2025-E-0872). Comments on date accuracy are due June 2, 2026, and petitions regarding due diligence may be filed by September 30, 2026.
Variance Application from BF Light Shows, Michigan
FDA CDRH received a variance application from BF Light Shows, a Michigan-based entity, seeking regulatory relief or alternative compliance pathway under FDA electronic product radiation control requirements. The application was filed under docket FDA-2026-V-2878.
Determination of Regulatory Review Period for VYLOY Patent Extension
FDA has determined the regulatory review period for VYLOY, a human biological product, as required by law for patent extension purposes. The Agency is publishing this notice to allow interested parties to comment on the determination or petition for redetermination regarding due diligence. Multiple patent extension applications (FDA-2025-E-0845 through FDA-2025-E-0872) are included in this notice.
FDA reviews patent extension for cancer drug VYLOY
FDA reviews patent extension for cancer drug VYLOY
VYLOY Regulatory Review Period Determination for Patent Extension
The FDA has determined the regulatory review period for VYLOY, a human biological product, as required by law for patent extension purposes. The notice solicits public comments on the accuracy of the published dates and allows interested parties to petition FDA regarding whether the applicant acted with due diligence during the review period. Comments on date accuracy are due June 2, 2026, and due diligence petitions are due September 30, 2026.
FDA Complaint Regarding Tobacco Product Regulations
The FDA Center for Tobacco Products filed a complaint under docket FDA-2026-H-2955-0001. The complaint has been closed for further comments. The specific allegations and parties involved are not publicly viewable as the underlying documents are not available for download on regulations.gov.
Tobacco Product Citizen Complaint
FDA Center for Tobacco Products received and closed a citizen complaint (FDA-2026-H-3165) for comments. The complaint is now in closed status with no documents available for public review. No regulatory action or compliance requirements identified.
VYLOY Patent Extension Regulatory Review Period Determination
FDA has determined the regulatory review period for VYLOY, a human biological product, and is publishing this determination as required by law for patent term extension applications. Interested parties may submit comments on the dates or petition FDA regarding due diligence. Comment deadline is June 2, 2026, and petition deadline is September 30, 2026.
EMRELIS Patent Extension Regulatory Review Period Determination
FDA has determined the regulatory review period for EMRELIS, a human biological product, for purposes of patent extension under federal law. The notice opens a public comment period until June 2, 2026, and allows interested parties to petition FDA regarding the applicant's due diligence by September 30, 2026. This determination affects the calculation of any patent term extension.
FDA Complaint Filed with Center for Tobacco Products
FDA Center for Tobacco Products filed a complaint under docket FDA-2026-H-3164-0001. The complaint has been closed for comments, indicating the administrative filing process is complete. No documents are available for public review at this time.
Determination of Regulatory Review Period for ZIIHERA
FDA has determined the regulatory review period for ZIIHERA, a human biological product, as required by law for patent extension calculations. The notice invites comments on the determination and sets deadlines for challenges. Interested parties may submit comments by June 2, 2026, and petitions regarding due diligence by September 30, 2026.
ACHC Hospice Accreditation Program Reapproved by CMS
CMS has approved the reapplication of Accreditation Commission for Health Care Inc. (ACHC) as a national accrediting organization for hospice programs under Section 1865(a)(1)(A) of the Social Security Act. The approval term runs from November 27, 2025 through November 27, 2031. This allows ACHC-accredited hospices to receive deemed status for Medicare and Medicaid participation in lieu of state survey agency reviews.
ACHC Critical Access Hospital accreditation approved by CMS
CMS announces continued approval of the Accreditation Commission for Health Care Inc. (ACHC) as a national accrediting organization for critical access hospitals (CAHs) participating in Medicare or Medicaid programs. The approval extends for six years from December 27, 2025, through December 27, 2031, maintaining the deemed status pathway for CAHs.
Booboo Cooler Trademark - Adhesive Bandages
USPTO published trademark application TM99739851 for "BOOBOO COOLER" covering adhesive bandages in International Class 005 (pharmaceuticals). The application was filed on April 1, 2026, and published for opposition on April 2, 2026, initiating a standard 30-day opposition window during which third parties may challenge the registration.
DR.NRCOCO Trademark Application - Medical Goods Class 005
USPTO published trademark application TM99739653 for DR.NRCOCO covering medical and pharmaceutical goods including disinfectants, iodine, vitamins, dietary supplements, antiseptic wipes, and infant formula in Class 005. The mark was filed April 1, 2026 and published April 2, 2026, initiating a standard 30-day opposition period.
HARDNOX Trademark Application - Protein Beverages and Nutritional Supplements
USPTO published trademark application TM99739632 for HARDNOX covering protein-enriched beverages and nutritional supplements in International Class 005. The application, filed April 1, 2026, indicates intent to use the mark in commerce. Competitors in the protein supplement and nutritional beverage space have a three-month window to file oppositions if they believe the mark creates confusion with existing trademarks.
Firo Labs Trademark - Disposable Pet Pads
USPTO published trademark application TM99739512 for "FIRO LABS" covering disposable housebreaking and house training pads for pets (Class 005). The application, filed April 1, 2026, is classified as Intent-to-Use. Third parties may monitor this application for potential conflicts with existing trademarks.
ISSĒL Intent-to-Use Trademark Application
USPTO received an intent-to-use trademark application for ISSĒL (Serial No. TM99702093) in Class 5 covering medical and cosmetic goods including bandages, antiseptics, antibiotic preparations, and cosmetics. The application was filed on March 13, 2026, under an intent-to-use basis.
ZIORA Intent-to-Use Trademark Application for IVF Biotechnology
USPTO published trademark application TM99693848 for ZIORA filed by a biotech company, covering biochemicals for scientific use, medical devices for in vitro fertilization treatment, and cryopreservation kits. The intent-to-use application was filed March 10, 2026, and published April 2, 2026, initiating the opposition period.
SKIN SOURCE Trademark Application - Intent to Use
USPTO filed trademark application TM98748889 for "SKIN SOURCE" covering nutritional supplements for promoting healthy skin. The application was filed on September 13, 2024, under an intent-to-use basis. This is a routine trademark registration record with no compliance obligations for third parties.
DAYSONA Trademark Application - Nutritional Supplements
The USPTO received a trademark application (TM99739674) for DAYSONA covering nutritional supplements, vitamins, mineral supplements, dietary supplements, probiotic supplements, and amino acid products in Class 5. Filed as an Intent to Use application on April 1, 2026, this establishes priority rights for the applicant in the nutritional supplements market.
METRODORA Intent to Use Trademark - Multisystem Disorder Pharmaceuticals
USPTO received an Intent to Use trademark application TM97023419 from METRODORA for pharmaceutical preparations in Class 5 covering treatments for complex or rare multisystem disorders. The application includes pharmaceuticals for conditions such as autoimmune disorders, neurological disorders, gastrointestinal disorders, and pain management. No regulatory obligations or compliance deadlines are associated with this trademark filing.
SALIOGASE Trademark Application
USPTO received trademark application TM90517616 for SALIOGASE under Class 005 (Pharmaceuticals). The application, filed as Intent to Use, covers pharmaceutical preparations for treating genetically driven, neurological, gastrointestinal, metabolic, immunological, oncological, and other specified disorders. Related goods include scientific reagents, nucleic acids, and nucleotides for research and medical purposes.
Desavo Trademark Application - Sanitizing Wipes
USPTO received trademark application TM90514865 for DESAVO (intent-to-use basis) covering sanitizing wipes and hand-sanitizing preparations, filed February 5, 2021. The application remains pending. Third parties have an opportunity to review and potentially oppose the registration within the prescribed period.
Ambrx Trademark Application - Cancer Bio-therapeutics
USPTO published Ambrx's Intent to Use trademark application (TM90487620) for biological and biochemical preparations used in cancer treatment. The application covers protein expression systems for generating novel bio-therapeutics, including bio-conjugated peptides, therapeutic proteins, monoclonal antibodies, and bi/multi-specific medicines. This Class 005 pharmaceutical trademark was filed on January 25, 2021.
CDC DELTA Cooperative Agreement Public Comment
CDC has opened a 52-day public comment period for the DELTA Cooperative Agreement (Docket CDC-2026-0364-0001) on Regulations.gov. The comment form allows individuals and organizations to submit feedback on the proposed cooperative agreement. Comments may be submitted as individuals, organizations, or anonymously.
Urban Health Leaders Renew Commitment to Accelerate Life-Saving Action in Cities
The World Health Organization, Bloomberg Philanthropies, Vital Strategies, and the Municipal Health Secretariat of Rio de Janeiro co-hosted the 2026 Partnership for Healthy Cities Summit in Rio de Janeiro, bringing together health officials from 55 cities. Baltimore, USA announced it will join the Partnership to focus on overdose prevention. Cities showcased initiatives including tobacco control, healthy school food environments, and heat health action protocols.
Updated Opioid Dependence Treatment and Overdose Prevention Guidelines
WHO announced updates to guidelines for opioid dependence treatment and overdose prevention, including new conditional recommendations for long-acting injectable buprenorphine alongside continued strong recommendations for methadone and oral buprenorphine. The full guidelines are expected later in 2026 or early 2027. Currently, fewer than 10% of approximately 64 million people worldwide with drug use disorders receive treatment.
WHO Global Consultation on Public Health and Social Measures for Health Emergencies
The World Health Organization convened its third global technical consultation on Public Health and Social Measures (PHSM) with over 120 experts from 44 Member States on 24-26 March 2026. The consultation advanced work on PHSM Decision Navigator tools, epidemic influenza modules, and community-centred implementation approaches, responding to World Health Assembly Resolution 78.3 on strengthening the evidence base for PHSM.
WHO SAGE Meeting Immunization Progress Challenges Ahead
WHO published Director Kate O'Brien's March 2026 message summarizing the Strategic Advisory Group of Experts on Immunization (SAGE) meeting discussions. The advisory highlighted that immunization has saved over 150 million lives in 50 years while noting that nearly 20 million children missed at least one vaccine dose in 2024. Discussions addressed COVID-19 vaccination guidance, typhoid vaccination strategies, polio eradication, and the path beyond Immunization Agenda 2030.
Vyloy Patent Extension Regulatory Review Period Determination
FDA has determined the regulatory review period for VYLOY, a human biological product, and published this notice as required by law. The determination is relevant to patent extension applications submitted to USPTO. Interested parties may submit comments by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.
FDA patent extension review, Injectafer, ends Sep 30
FDA patent extension review, Injectafer, ends Sep 30
ENFLONSIA Patent Extension Regulatory Review Period Determination
FDA published a notice determining the regulatory review period for ENFLONSIA, a human biological product, for purposes of patent extension under 35 U.S.C. 156. The notice allows interested parties to comment on the accuracy of published dates by June 2, 2026, and to petition FDA regarding the applicant's due diligence by September 30, 2026. Docket No. FDA-2025-E-3626.
CTP Complaint Against Tobacco Product Company
The FDA Center for Tobacco Products filed and closed a complaint (FDA-2026-H-3163-0001) on April 3, 2026. The specific allegations, respondent identity, and resolution details are contained in the attached complaint document. This represents routine enforcement activity under FDA's tobacco product authority.
EMRELIS Regulatory Review Period Determination for Patent Extension
FDA has determined the regulatory review period for EMRELIS, a human biological product, and published this notice as required by law for patent extension purposes under 35 U.S.C. 156. The determination affects the patent term extension calculation for the product's New Drug Application submitted to USPTO.
ZIIHERA Regulatory Review Period Determination for Patent Extension
FDA has determined the regulatory review period for ZIIHERA, a human biological product, as required by law for patent extension applications. The notice publishes these dates and provides timelines for public comments and petitions. Comments on date accuracy are due June 2, 2026, and petitions regarding due diligence are due September 30, 2026.
Additional MRI Monitoring Recommendation for Leqembi Patients
FDA issued a Drug Safety Communication recommending additional MRI monitoring for patients taking Leqembi (lecanemab). The agency is requiring updated prescribing information to include MRI monitoring between the 2nd and 3rd infusion, earlier than the current recommendation for MRI before the 5th infusion. This change aims to identify amyloid-related imaging abnormalities with edema (ARIA-E) earlier to prevent serious and potentially fatal events.
HHS Reorganization Removing Office of Chief Information Officer
The Department of Health and Human Services published a notice announcing the reorganization of its administrative structure, specifically removing the Office of Chief Information Officer from the organizational chart. The change is effective upon publication date. This is an internal administrative restructuring that affects the agency's chain of command and information technology governance.
Importer of Controlled Substances Application: Lipomed/LGC Standards
The Drug Enforcement Administration published a notice of application by Lipomed/LGC Standards for registration as an importer of controlled substances. The notice invites public comments on the application before a final registration decision is made. Comments must be submitted within 31 days of the publication date.
Bulk Manufacturer of Controlled Substances Application: Purisys LLC
The Drug Enforcement Administration published a notice of application from Purisys, LLC to register as a bulk manufacturer of controlled substances. The notice is published pursuant to 21 U.S.C. 823 and invites public comment on the application. Comments must be submitted within 60 days of the publication date.
Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute
DEA published notice that Research Triangle Institute has applied to become a bulk manufacturer of controlled substances. The notice opens a 60-day public comment period ending June 2, 2026. This is a routine application notice, not an approval or denial.
Joint Commission Home Health Agency Accreditation Program Renewal Application
CMS published a notice seeking public comments on the Joint Commission's application for continued CMS approval of its Home Health Agency accreditation program. The Joint Commission currently holds deeming authority for Medicare and Medicaid-participating home health agencies. Comments on this accreditation renewal application must be submitted by May 4, 2026.
ACHC Critical Access Hospital Accreditation Program Continued Approval
CMS published notice of the Accreditation Commission for Health Care Inc. (ACHC) application for continued approval of its Critical Access Hospital accreditation program under Medicare. The decision, if granted, would be effective from December 27, 2025, through December 27, 2031. This notice informs the public of the application and CMS's review process.
ACHC Medicare Hospice Accreditation Program CMS Approval
CMS published notice of approval for the Accreditation Commission for Health Care Inc. (ACHC) to continue its CMS-approved hospice accreditation program. The decision applies from November 27, 2025, through November 27, 2031. This routine approval allows ACHC to continue conducting accreditation surveys for Medicare and Medicaid-participating hospice providers.
NIH Center Scientific Review Closed Meetings
The National Institutes of Health Center for Scientific Review announced five closed meetings scheduled for late April 2026 to review grant applications. The meetings will address research in aging, oral/dental sciences, genetic therapies, training programs, and mental health/Alzheimer's disease interventions. Meetings are closed under Federal Advisory Committee Act exemptions to protect confidential grant information and applicant privacy.
Human Antibodies With Anti-Lymphocyte Specificities - Licensing Availability
NIH/NIAID issued a notice announcing availability for licensing of novel human IgM antibodies (HHS Ref No. E-025-2025) developed for treating B-cell cancers and autoimmune conditions. The antibodies demonstrated effective B-cell killing at concentrations as low as 0.01 nanomolar. Inventors Dr. Ainhoa Pérez-Díez and Dr. Irini Sereti developed this technology. Companies may contact Benjamin Hurley at 240-276-5489 to pursue licensing.
Center for Scientific Review Amends Meeting Notice
The NIH Center for Scientific Review issued an amended meeting notice changing the dates for the Neuromodulation and Imaging of Neuronal Circuits Study Section from April 16-17, 2026 to July 9-10, 2026. The meeting remains closed to the public. This is an administrative correction to a previously published Federal Register notice.
Board of Scientific Counselors, NIDA - Notice of Closed Meeting
The National Institutes of Health published a notice announcing a closed meeting of the Board of Scientific Counselors, NIDA, scheduled for May 12, 2026. The virtual meeting will review and evaluate personnel qualifications, performance, and competence of individual investigators under the Federal Advisory Committee Act. The meeting is closed pursuant to 5 U.S.C. 552b(c)(6) to protect personal privacy.
Determination of Regulatory Review Period for VYLOY Patent Extension
The FDA has determined the regulatory review period for VYLOY, a human biological product, for patent extension purposes. The Agency is publishing this notice as required by law due to patent extension applications submitted to the USPTO. Comments regarding date corrections must be submitted by June 2, 2026, and petitions for due diligence determinations may be filed by September 30, 2026.
Determination of Regulatory Review Period for Patent Extension; ENFLONSIA
The FDA has determined the regulatory review period for ENFLONSIA, a human biological product, and published this notice as required by 21 CFR Part 60. The notice allows any person to submit comments correcting dates by June 2, 2026, and any interested party may petition FDA by September 30, 2026 regarding due diligence during the review period.
Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
The FDA has determined the regulatory review period for EMRELIS, a human biological product, and published this notice as required by law for patent extension purposes. The determination affects the calculation of patent term extension under federal law. Comments on the determination may be submitted until June 2, 2026, and petitions regarding due diligence may be filed until September 30, 2026.
Determination of Regulatory Review Period for HYMPAVZI Patent Extension
The FDA has determined the regulatory review period for HYMPAVZI, a human biological product, and published this notice as required by law. The determination was made in connection with an application to the USPTO for extension of a patent claiming the product. Interested parties may submit comments or petitions regarding the determination.
Customer Service Satisfaction Survey Collection
The FDA is seeking public comments on a proposed information collection for customer service satisfaction surveys. Under the Paperwork Reduction Act of 1995, federal agencies must publish notice and allow 60 days for public comment on proposed collections. Comments are due by June 2, 2026.
Determination of Regulatory Review Period for INJECTAFER Patent Extension
FDA has determined the regulatory review period for INJECTAFER (ferric carboxymaltose injection) and published this notice as required by law. The determination is needed for the USPTO to calculate patent term extension under the Hatch-Waxman Act. Comments on the calculation may be submitted by June 2, 2026; petitions regarding due diligence may be filed by September 30, 2026.
ZIIHERA Regulatory Review Period Determination for Patent Extension
The FDA has determined the regulatory review period for ZIIHERA, a human biological product, and is publishing this notice as required by law for patent extension purposes under 21 USC 356. The determination is being forwarded to the USPTO for use in processing the patent extension application. Interested parties may submit comments on the accuracy of published dates or petition FDA regarding due diligence during the review period.
Determination of Regulatory Review Period for ENCELTO Patent Extension
The FDA has determined the regulatory review period for ENCELTO, a human biological product, and published this notice as required by law for patent extension purposes under 35 U.S.C. 156. The determination opens a public comment period through June 2, 2026, and allows petitions regarding due diligence through September 30, 2026.
State Meat and Poultry Inspection Programs Information Collection
FSIS is requesting public comments on a revision to its State Meat and Poultry Inspection Programs information collection (OMB No. 0583-0170), adding 204 burden hours due to a new State inspection program. Comments are due June 1, 2026. This standard Paperwork Reduction Act submission has an approval expiration of August 31, 2026.
Boncresa biosimilar to Prolia approved for osteoporosis
FDA approved Boncresa (denosumab-b00) as a biosimilar to Prolia (denosumab), providing a new treatment option for patients with osteoporosis. The product is indicated for postmenopausal women, men, and patients with glucocorticoid-induced osteoporosis at high risk for fracture, as well as bone loss from hormone ablation therapy for cancer. Boncresa is administered as a 60 mg subcutaneous injection every 6 months.
Oziltus Biosimilar to XGEVA Approved for Bone Metastases and Multiple Myeloma
FDA approved Oziltus (denosumab-mobz), a biosimilar referencing XGEVA (denosumab), for prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors. The drug is also approved for giant cell tumor of bone and hypercalcemia of malignancy. Marketed by Amneal Pharmaceuticals LLC, this approval expands treatment options for bone-related oncology conditions.
Aqueous Pharmaceutical Formulation of Hydrocortisone Sodium Phosphate and Monothioglycerol
The USPTO published patent application US20260091042A1 filed by Antares Pharma, Inc. (inventors Xiaoming Chen, Shaowei Ong) covering aqueous pharmaceutical formulations comprising hydrocortisone sodium phosphate and monothioglycerol as an antioxidant, with optional buffer components including monobasic/dibasic sodium phosphate or disodium EDTA. The application also discloses methods of treating diseases or disorders by administering the formulation. This is routine intellectual property protection activity for a pharmaceutical formulation invention.
Carbasalate Calcium Application for Hydrocephalus Treatment
The USPTO published patent application US20260091044A1 by Tianjin University covering the use of carbasalate calcium as the sole or primary active ingredient for treating hydrocephalus. The application includes zebrafish model experimental data demonstrating significant reduction in fourth ventricle area and improvements in swimming metrics. No regulatory compliance deadlines or penalties apply to this patent application publication.
Doxycycline Mouthwash for COVID-19 Prevention
USPTO published patent application US20260091045A1 for a preventative mouthwash containing doxycycline (100-400mg dosage) for COVID-19 infection prevention. Inventor Bruce Roseman's application describes a gargling method using 5-20mL of the mouthwash twice daily for 5-10 days. The application was filed October 2, 2024 and published April 2, 2026.
Compositions and Methods for Treating Mycobacterium Infections
USPTO published patent application US20260091043A1 for compositions and methods treating infections caused by Mycobacteriaceae family pathogens, including those causing tuberculosis. Inventors John David Wild, Jeremy Joseph Yang, and Sean Ekins filed the application on September 20, 2023. The application claims priority to Application No. 19113756 and covers novel therapeutic approaches to bacterial infections.
PFIC Treatment Methods Using IBAT Inhibitor Odevixibat
USPTO published patent application US20260091040A1 for methods of treating progressive familial intrahepatic cholestasis (PFIC) using IBAT inhibitor odevixibat. Inventors include Per-Göran Gillberg, Jan Mattsson, Pat Horn, and Paresh Soni. The application covers reducing pruritus scores, serum bile acid concentration, improving liver parameters, height normalization, weight improvement, and sleep quality.
Methods of Treating Heavy Menstrual Bleeding
USPTO published patent application US20260091041A1 for methods of treating heavy menstrual bleeding with or without uterine fibroids. The application claims a method using compound 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)-butyric acid or salts thereof in combination with estrogens and progestogens. Fifteen inventors are named including Kristof Chwalisz, Jane Castelli-Haley, and others.
Sepiapterin Methods for BH4 Disorders
USPTO published patent application US20260091037A1 for sepiapterin compositions and methods treating BH4-related disorders. Inventors Neil Smith and Jonathan Reis filed the application on May 13, 2025. The application covers methods for increasing sepiapterin plasma, CSF, and brain exposure for therapeutic use.
Elagolix dosing regimens for GnRH receptor antagonists
USPTO published patent application US20260091036A1 for dosing regimens of Elagolix (a GnRH receptor antagonist) and related compounds. The application claims methods to minimize bone mineral density changes in subjects suffering from endometriosis, adenomyosis, PCOS, or uterine fibroids. Filing date August 26, 2025.
Modified Release Minoxidil Compositions and Methods for Oral Administration
The USPTO published patent application US20260091035A1 by inventor Reid Waldman covering modified release minoxidil pharmaceutical formulations for oral daily dosing to treat hair loss. The application claims compositions including slow modified release vehicles containing minoxidil or pharmaceutically acceptable salts, optionally combined with additional active agents. Filing date was December 9, 2025.
Modified Release Minoxidil for Hair Loss Treatment
The USPTO published patent application US20260091034A1 by inventor Reid Waldman for a modified release oral formulation of minoxidil for treating hair loss. The application discloses pharmaceutical compositions including daily doses of modified release minoxidil, potentially combined with additional active agents, delivered via a slow release vehicle. The filing date is December 4, 2025, with publication on April 2, 2026.
FGFR3 Antagonist for Skeletal Disorders Treatment
The USPTO published patent application US20260091033A1 for an FGFR3 antagonist for treating skeletal disorders linked to abnormal FGFR3 activation. The application, filed by inventors LEGEAI-MALLET, MUNNICH, BUSCA, and BARBAULT on January 15, 2025, covers compositions and methods for treatment. This publication represents a new patent application and creates no immediate compliance obligations for industry.
Amorphous Solid Dispersions Patent - Intra-Cellular Therapies
USPTO published patent application US20260091032A1 by Intra-Cellular Therapies, Inc. for stable amorphous solid dispersions of a quinoxaline-derived compound with potential applications in neurological and metabolic disorders. The application, filed August 6, 2025, contains 29 CPC classifications spanning formulations, compounds, and therapeutic indications.
CGRP Receptor Antagonists for Treating Chemotherapy-Induced Nausea and Vomiting
The USPTO published patent application US20260091031A1 by inventor Alberto Chiarugi covering a method of using CGRP receptor antagonists (gepants) for treating chemotherapy-induced nausea and vomiting (CINV). The application claims the use of these migraine-approved drugs to target CGRP neuropeptides to prevent and counteract drug-induced nausea including CINV.
HIGH-DOSE NALOXONE FORMULATION
The USPTO published patent application US20260091030A1 for high-dose Naloxone formulations designed to treat ultra-potent synthetic opioid overdose. Invented by Gita Shankar and Suresh Potharaju, the formulation comprises naloxone hydrochloride with preservatives, buffering agents, and tonicity modifiers. The application was filed September 1, 2023, and published April 2, 2026.
Pridopidine for ALS Treatment
USPTO published patent application US20260091028A1 by Prilenia Neurotherapeutics Ltd. for a method of treating amyotrophic lateral sclerosis (ALS) using pridopidine. The application claims therapeutic use of pridopidine or a pharmaceutically acceptable salt for human subjects afflicted with ALS. Application No. 19391284 was filed on 2025-11-17.
Stilbene Derivatives as AHR Regulators with Improved Photostability
The USPTO published patent application US20260091027A1 for stilbene derivatives serving as aryl hydrocarbon receptor (AHR) regulators with improved photostability over the marketed drug Benvitimod. The application, filed September 19, 2023 under Application No. 19113670, covers compounds of formula I-1, their stereoisomers, salts, and prodrugs, along with preparation methods for gram-to-kilogram scale synthesis.
Methods of Treating Inflammatory Diseases with Formula I and II Compounds
The USPTO published patent application US20260091026A1 covering compounds of Formula (I) and Formula (II), and their use in treating inflammatory diseases. The application was filed December 5, 2025, and published April 2, 2026, naming inventors Robert Joseph Moreau, Naomi S. Rajapaksa, David C. Tully, and others. The claimed subject matter includes novel compounds, pharmaceutical compositions, and methods of treatment for inflammatory diseases and disorders.
Markers for the Diagnosis of Biochemical Recurrence in Prostate Cancer
USPTO published patent application US20260092922A1 for biomarkers and diagnostic methods related to prostate cancer biochemical recurrence (BCR). The application (No. 19207308, filed May 13, 2025) includes 9 inventors and covers methods for detecting BCR biomarkers, compositions, and diagnostic kits. This is a routine patent publication with no new regulatory requirements.
Medline Angiographic Kit Recall - Syringe Adaptor Unwinding Risk
Health Canada issued a Type I recall for Medline Namic Custom Angiographic Kits (catalog numbers 60700513, 60701152, 60700465) due to potential risk of the syringe rotating adaptor unwinding during use, which may cause procedural delays or death. Healthcare facilities must immediately stop using affected Namic RA Syringes and discard them. Recall identification number RA-81841.
AneurysmFlow Medical Device Recall - Unreliable mafa Ratio
Health Canada issued a Type II recall for AneurysmFlow software (Model 1.4) manufactured by Philips Medical Systems Nederland B.V. The recall addresses unreliable mafa ratio measurements that provide inaccurate prognostic information for aneurysm occlusion following flow diverter stent treatment. Despite existing cautions in the instructions for use, the displayed mafa ratio may still influence intraprocedural clinical decisions, potentially resulting in incorrect patient treatment choices.
Olympus Connecting Tubes Premature Failure Recall
Health Canada issued a Type II medical device recall for Olympus Medical Systems Corp. connecting tubes (models MAJ-2110 through MAJ-2330) due to premature failure where lock levers detach or break earlier than expected in Version 2 products. Olympus will remove prior versions from the market and replace them with the current design. Affected parties should identify, quarantine, and contact the manufacturer for replacement.
Aved Products Recall - Unauthorized Ophthalmic Solutions
Health Canada issued a Type III recall for Aved ophthalmic solutions from Labtician Ophthalmics, Inc. Nine products were sold without market authorization (DIN) in Canada due to third-party branding issues. Affected products include various atropine sulfate solutions (0.01%-0.05%), fluorescein/proparacaine, insulin ophthalmic, mitomycin, moxifloxacin, and combination steroid/antibiotic solutions. Distribution is national in Canada with recall classification RA-81839.
PRODRUGS OF RILUZOLE AND THEIR METHOD OF USE
USPTO published patent application US20260091024A1 for substituted riluzole prodrug compositions useful for treating cancers including melanoma, breast cancer, brain cancer, and prostate cancer. The prodrugs are designed for oral administration with enhanced stability to hepatic metabolism, releasing riluzole in plasma via enzymatic or biophysical processes. Inventors include Jay Edward Wrobel, Allen B. Reitz, Jeffrey Claude Pelletier, Garry Robert Smith, and Haiyan Bian. Application No. 19064963 was filed February 27, 2025.
Gel-Chewable Dosage Form Patent Application
USPTO published patent application US20260091023A1 for a gel-chewable dosage form drug delivery system. Inventors Vipul Dave and Anurag Pandey disclose a formulation with multiple active pharmaceutical ingredients, where at least one is encapsulated in lipid material embedded in the gel base. The invention includes methods for treating diseases or disorders of the gastrointestinal tract.
Seaweed Polyphenol Antioxidant Extract System and Method
The USPTO published patent application US20260091326A1 by inventor Sabrena Mackenzie, disclosing a process for producing a high-quality polyphenol-containing antioxidant extract from seaweed biomass. The process yields residual biomass available for alginate and fucoidan production. The application (No. 19110368) was filed September 8, 2023 and classified under CPC codes B01D 11/0288 and A61K 36/03.
Pharmaceutical Composition for Treating Fatty Liver Disease
USPTO published Shionogi & Co., Ltd.'s patent application US20260091022A1 for a pharmaceutical composition treating fatty liver disease. The application was filed December 9, 2025, and published April 2, 2026, covering a compound represented by Formula (I) or a pharmaceutically acceptable salt thereof. CPC classifications are A61K 31/4184 and A61P 1/16.
Bladder Cancer Classification and Treatment Using Atezolizumab
The USPTO published patent application US20260092117A1 disclosing methods for classifying and treating bladder cancer (including locally advanced or metastatic urothelial cancer) using atezolizumab, a PD-1 axis binding antagonist. The application covers diagnostic methods, treatment regimens, compositions, kits, and articles of manufacture for bladder cancer classification and therapy. The application was filed on April 4, 2025.
Multivalent FZD4, Wnt Co-receptor, and VEGF Binding Molecules
EyeBiotech Limited published US Patent Application US20260092125A1 for multivalent antibody binding molecules comprising FZD4 receptor binding, LRP5 co-receptor binding, and VEGF binding domains that activate the Wnt/β-catenin signaling pathway. The application covers the molecules, nucleic acids, vectors encoding them, and methods of use. Inventors include Paul E. Stephens, Michael John Davies, Yin Shan Eric Ng, Masahisa Handa, and Alexander V. Loktev. The application was filed September 4, 2025, and published April 2, 2026.
B7H3/PDL1 Bispecific Antibody Cancer Therapeutic
The USPTO published patent application US20260092116A1 by DARTSBIO Pharmaceuticals Ltd. covering a B7H3/PDL1 bispecific antibody for cancer treatment. The invention comprises a monoclonal antibody targeting PDL1 linked to nano-antibodies targeting B7H3, designed to relieve T-cell inhibition while targeting tumor cells. The application was filed October 13, 2022, with six inventors.
Anti-CTLA-4 antibodies with variant Fc regions
The USPTO published patent application US20260092115A1 for anti-CTLA-4 antibodies featuring variant Fc regions and methods of production and use. The application (No. 19407391) was filed December 3, 2025, by a team of 11 inventors including researchers from pharmaceutical companies. The invention relates to therapeutic antibodies modified to enhance effector functions through Fc region engineering.
Treatment of Lung Cancer Using Anti-PD-1 Antibody Combination
The USPTO published Bristol-Myers Squibb Company's patent application (US20260092114A1) for a method of treating lung cancer using a combination of an anti-PD-1 antibody administered by infusion in under 60 minutes and optionally an anti-CTLA-4 antibody administered in under 90 minutes. The application was filed on September 29, 2025.
CD28/OX40 Bispecific Antibodies for Solid Organ Transplant Rejection Treatment
The USPTO published patent application US20260092113A1, filed by Bristol-Myers Squibb, covering methods for treating solid organ transplant rejection using CD28/OX40 bispecific antibodies. The application (No. 19237572) claims a multispecific binding protein with a VHH domain targeting CD28 and a VH/VL domain targeting OX40. Inventors include Rami Lissilaa, Benjamin Suratt, and Jessica Voss.
Anti-CTLA-4 Antibodies for Treating Adenoid Cystic Carcinoma
The USPTO published patent application US20260092112A1 covering uses of anti-CTLA-4 antibodies for treating adenoid cystic carcinoma. Inventors Yang Liu and Pan Zheng filed Application No. 19112015 on September 15, 2023, with the application published April 2, 2026. The invention claims therapeutic applications of anti-CTLA-4 antibodies specifically for adenoid cystic carcinoma.
TREM2 antibodies patent, neurodegenerative disease treatment, 2nd Apr
TREM2 antibodies patent, neurodegenerative disease treatment, 2nd Apr
Treatment of Cancer Using Anti-HLA-G/Anti-CD3 Bispecific Antibody and 4-1BB Agonist
The USPTO published patent application US20260092118A1 by Hoffmann-La Roche Inc., covering a method for treating cancer using an anti-HLA-G/anti-CD3 bispecific antibody in combination with a 4-1BB (CD137) agonist. The application (No. 19325175) was filed September 10, 2025, and lists Meher Majety, Carina Hage, and Johannes Sam as inventors. This publication represents an early-stage intellectual property filing for a bispecific antibody-based cancer therapy.
Anti-NRP2 Antibody Compositions and Methods for Treating NRP2-Associated Diseases
The USPTO published patent application US20260092122A1 for affinity-matured and humanized antibodies targeting human neuropilin-2 (NRP2) polypeptides. The application (No. 19293892, filed August 7, 2025) names six inventors and covers therapeutic compositions and methods for modulating NRP2 activity to treat NRP2-associated diseases, including cancer (A61P 35/04).