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USDA Removes 48-Hour Pre-Export Examination Requirement for Horse Imports

USDA-APHIS has removed the requirement that horses imported to the United States be accompanied by documentation of pre-export examination within 48 hours of departure from the port of embarkation, endorsed by a salaried veterinary medical officer. The agency determined that logistical barriers prevented affected parties from meeting this requirement as written. The final rule, effective May 11, 2026, removes § 93.314(a)(5) while retaining other horse import regulations including port-of-entry inspections and quarantine protocols.

Priority review Rule Agriculture
CMS Newsroom
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FY 2027 Medicare Hospital Inpatient and Long-Term Care Payment Rates Proposed Rule

CMS issued a proposed rule on April 10, 2026, updating Medicare payment policies and rates for inpatient hospitals and long-term care hospitals for FY 2027. The proposed rule would expand the Comprehensive Care for Joint Replacement (CJR-X) model nationwide, covering hip, knee, and ankle replacements in inpatient and outpatient settings, effective October 1, 2027. The rule also includes proposed changes to Organ Acquisition and Reimbursement Appeals policies.

Priority review Consultation Healthcare
CMS Newsroom
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2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule

CMS has released the 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule (CMS-0062-P), which would extend electronic prior authorization requirements to cover drugs for Medicare Advantage organizations, state Medicaid and CHIP fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers. The rule also proposes adding small group market QHP issuers on the FF-SHOP as impacted payers and would require impacted payers to adopt specific HL7 FHIR standards for electronic prior authorization transactions under HIPAA.

Priority review Consultation Healthcare
CMS Newsroom
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Proposes Faster Drug Prior Authorization Decisions with 24-Hour Urgent Deadline

CMS proposes a rule establishing mandatory prior authorization decision deadlines for drugs: 24 hours for urgent requests and 72 hours for standard requests. The rule would expand electronic prior authorization requirements to include drugs under Medicare Advantage, Medicaid, CHIP, Qualified Health Plans, and FF-SHOP. Impacted payers would be required to publicly report prior authorization metrics including approval rates, denial rates, appeal outcomes, and decision timeframes.

Priority review Consultation Healthcare
CMS Newsroom
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CMS Proposes CJR Model National Expansion to All Hospitals

CMS announced a proposed rule to expand the Comprehensive Care for Joint Replacement (CJR-X) Model nationwide through the FY2027 Hospital IPPS and LTCH PPS proposed rule. Beginning October 1, 2027, the model would be mandatory for most hospitals, making it the first nationwide test of an episode-based payment model for joint replacements. The model holds hospitals responsible for Medicare spending on joint replacement surgery, hospital stay, and 90 days of post-acute recovery care.

Priority review Notice Healthcare
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CMS Proposed Rule Comment Form, 60 Days

CMS has published a comment form on regulations.gov for proposed rule CMS-2026-1256-0001, opening a 60-day public comment period. The form allows individuals and organizations to submit feedback on the proposed rule. The actual subject matter and regulatory requirements of the underlying proposed rule are not detailed in this comment form document.

Routine Notice Healthcare
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CMS-1849-P Proposed Rule - Public Comment Deadline June 9

CMS published a proposed rule (CMS-1849-P) soliciting public comments on changes to Medicare and Medicaid program requirements. The comment deadline is June 9. Healthcare providers, accountable care organizations, and other stakeholders affected by CMS regulations should review the proposal and prepare comments.

Priority review Consultation Healthcare
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Small Molecule NVL2 Inhibitors, Dibenzothiazepinone and Dibenzazepinone Compounds for Cancer Treatment

The USPTO published patent application US20260097047A1 assigned to the Board of Regents, The University of Texas System, covering dibenzothiazepinone and dibenzazepinone-based small molecule inhibitors targeting the ribosome biogenesis factor NVL2 for cancer treatment. The application includes methods for treating cancers, pharmaceutical compositions, and screening methods for candidate therapeutics.

Routine Notice Intellectual Property
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Large-Scale Liposomal Aminoglycoside Manufacturing Method

USPTO published patent application US20260096989A1 by Insmed Incorporated for large-scale manufacturing of liposomal aminoglycoside drug formulations. The method uses a specific lipid-to-drug stream flow rate ratio to achieve high encapsulation efficiency with a lipid-to-drug weight ratio below 1:1.

Routine Notice Intellectual Property
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Cardiac Myosin Inhibitor Aficamten for Hypertrophic Cardiomyopathy

Cardiac Myosin Inhibitor Aficamten for Hypertrophic Cardiomyopathy

Routine Notice
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Cannabinoid Analogs Cancer Treatment Patent Application

USPTO published patent application US20260097049A1 by BlackStone Therapeutics LLC covering hexahydrocannabinol (HHC), hexahydrocannabidivarin (H4CBDV), and hexahydrocannabidivarin (H4CBDV) derivatives for cancer treatment and prevention. The application includes pharmaceutical compositions and methods of use for pancreatic and lung cancers.

Routine Notice Intellectual Property
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Ion Pair Liquid Crystal Formulations for Long-Acting Injectables of Poorly Soluble Drugs

USPTO published patent application US20260097044A1 by FORDOZ PHARMA Corp. disclosing ion pair liquid crystal formulations designed to solubilize poorly soluble drugs and enable controlled release via parenteral administration. The application covers ion pairs including Meloxicam-Dodecylamine, Sulfadiazine-Dodecylamine, Methotrexate-Dodecylamine, Levothyroxine-Dodecylamine, Meloxicam-Tridodecylamine, and Meloxicam-Bupivacaine incorporated into liquid crystal vehicles.

Routine Notice Intellectual Property
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Helperby Therapeutics Antimicrobial Combination Patent - Three Agents

USPTO published Helperby Therapeutics' patent application for antimicrobial combination therapy comprising three distinct antimicrobial agents. The invention covers combinations including ceftazidime, polymyxins, zidovudine, doxycycline, fosfomycin, levofloxacin, meropenem, rifampicin, and gentamicin for treating bacterial infections. This application was filed September 20, 2023.

Routine Notice Intellectual Property
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ModernaTX Betacoronavirus mRNA Vaccine Lipid Nanoparticle Patent Application

USPTO published patent application US20260097110A1 by ModernaTX, Inc. for betacoronavirus mRNA vaccines formulated in lipid nanoparticles. The application covers RNA vaccines, combination vaccines, and methods of using the vaccines and compositions. The filing was submitted December 5, 2025, with inventors Giuseppe Ciarametta and Sunny Himansu.

Routine Notice Intellectual Property
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Self-Attestation Form for Provider Recertification Under PRA

CMS published a 60-day Paperwork Reduction Act notice announcing a new Self-Attestation for Recertification form for Comprehensive Outpatient Rehabilitation Facilities (CORFs), Outpatient Physical Therapy/Speech Language Pathology (OPT/SLP), and Rural Health Clinics (RHCs) Providers and PXR Suppliers. The notice invites public comment on burden estimates and information collection aspects through June 9, 2026.

Routine Notice Healthcare
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Conditions of Coverage for Portable X-ray Suppliers, Reinstatement of Information Collection, Comments Due June 9, 2026

CMS published a 60-day PRA notice seeking public comment on reinstating an existing information collection regarding Conditions of Coverage for Portable X-ray Suppliers. The collection covers portable X-ray services performed in Skilled Nursing Facilities and Long-term Care settings under Medicare/Medicaid. Comments must be received by June 9, 2026.

Routine Consultation Healthcare
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AVID Medical Urgent Recall: Angiographic Syringes in Convenience Kits

FDA CDRH issued an Early Alert notifying the public that AVID Medical initiated an urgent medical device recall for convenience kits containing angiographic syringes affected by Medline's Namic RA Syringes recall. The recall involves 11 tray configurations with specific model numbers and UDI-DIs. Affected customers must identify, quarantine, and add warning labels to affected kits, with direction to remove and destroy Namic RA Syringes due to risk of serious injury or death.

Urgent Enforcement Medical Devices
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Anti-Lea Reagent Safety Alert - Diagast Immuno-Hematology

ANSM issued safety alert R2610123 regarding a security action taken by Diagast for its Anti-Lea Reagent (LE1) used in immuno-hematology testing. Medical biology laboratories using this diagnostic reagent must review the manufacturer's safety communication and take appropriate action. ANSM reference number R2610123.

Priority review Notice Medical Devices
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Monnal TEO Ventilator Field Safety Corrective Action - Air Liquide Medical Systems

ANSM published a safety notice regarding field safety corrective action R2531145 for Air Liquide Medical Systems' Monnal TEO ventilator. The manufacturer issued updated safety correspondence dated 10 April 2026 superseding the November 2025 notification. Healthcare establishments using this resuscitation ventilator must review the corrective action requirements directly from the manufacturer.

Urgent Enforcement Medical Devices
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Variance Approval Letter for Shane Parker

FDA CDRH issued a variance approval letter to Shane Parker under docket FDA-2025-V-5013. The variance grants an exception or deviation from standard CDRH regulatory requirements for a specific medical device matter. The approval letter (redacted version available) represents a binding regulatory determination by FDA.

Priority review Notice Medical Devices
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FDA Requests Comments on Medical Device Premarket Approval Information Collection Under PRA

FDA Premarket Approval, Comment Period Ends Jun 9

Priority review Consultation Medical Devices
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Suitability Petition - Emprise Pharma on Behalf of Shandong New Time

Emprise Pharma LLC filed a suitability petition with FDA on behalf of Shandong New Time Pharmaceutical Co., Ltd requesting agency determination on proposed changes to an approved drug product. The petition has been assigned docket number FDA-2026-P-3840-0001 and is under review by CDER.

Routine Notice Pharmaceuticals
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GSK Withdraws Wellcovorin (Leucovorin Calcium) NDA Approval

FDA withdrew approval of NDA 018342 for Wellcovorin (leucovorin calcium) tablets at GlaxoSmithKline's written request. GSK notified FDA that the drug products are no longer marketed. Existing inventory may continue to be dispensed until depleted or reaching expiration dates.

Routine Notice Pharmaceuticals
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Environmental Impact Statement Background Material

FDA published background material supporting an Environmental Impact Statement (EIS) for a pre-market submission (FDA-2026-P-3840). The document provides supporting context for environmental review of the regulated product or facility. Interested parties may review the materials on Regulations.gov.

Routine Notice Environmental Protection
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CDRH Acknowledgment Letter to Shane Parker - FDA-2025-V-5013

FDA CDRH issued an acknowledgment letter to Shane Parker in response to submission FDA-2025-V-5013. The acknowledgment letter confirms receipt of the submission but the actual document content is not publicly available due to personally identifiable information protections.

Routine Notice Medical Devices
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Color Additive Certification PRA Extension, Comments Due June 9, 2026

FDA is soliciting public comments on extending an existing information collection under the Paperwork Reduction Act concerning color additive certification. Comments must be submitted by June 9, 2026. This PRA notice follows standard federal procedures for renewing agency data collection authorizations.

Routine Consultation Food Safety
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FDA DMB Acknowledgement Letter to Emprise Pharma LLC

FDA Division of Manufacturing Standards (DMB) issued an acknowledgement letter to Emprise Pharma LLC on behalf of Shandong New Time Pharmaceutical Co., Ltd on April 10. The letter confirms receipt or filing status of a submission related to pharmaceutical manufacturing. This is standard administrative correspondence and does not constitute approval, denial, or any substantive regulatory determination.

Routine Notice Pharmaceuticals
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Food Additive Petitions Comments Due Jun 9

FDA is soliciting public comments on information collection requirements for food and color additive petitions, including labeling, master file submissions, and electronic submissions using Form FDA 3503. The 60-day comment period closes June 9, 2026. Comments will be posted to Docket No. FDA-2026-N-2743 on regulations.gov.

Routine Notice Food Safety
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ANDA vs 505(b)(2) Applications

FDA issued guidance clarifying distinctions between Abbreviated New Drug Applications (ANDAs) and 505(b)(2) applications for drug approvals. The document helps pharmaceutical manufacturers determine the appropriate regulatory pathway based on their drug product characteristics and supporting data requirements.

Priority review Guidance Pharmaceuticals
EMA News
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Severe Liver Injury Warning for Epilepsy Drug Ontozry

PRAC agreed on a Direct Healthcare Professional Communication for Ontozry (cenobamate) warning of severe liver injury cases with hepatic failure, most occurring when used alongside other anti-seizure medications. The committee recommended adding liver injury as a rare side effect (up to 1 in 1,000) to product information and issued new liver monitoring requirements for prescribers throughout treatment.

Priority review Guidance Pharmaceuticals
WHO News
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Kazakhstan First Central Asian Country with ML3 Status

WHO has recognized Kazakhstan as the first country in Central Asia to achieve Maturity Level 3 (ML3) status under the Global Benchmarking Tool for regulation of medicines and imported vaccines. This designation confirms Kazakhstan has a stable, well-functioning regulatory system meeting international standards for evaluating, approving, and monitoring health products. The milestone was achieved through the Committee for Medical and Pharmaceutical Control and the National Center for Expertise of Medicines and Medical Devices.

Routine Notice Pharmaceuticals
WHO News
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FAO/WHO/WOAH Establish Joint One Health Learning Taskforce

FAO, WHO, and WOAH jointly established the One Health Learning Taskforce to strengthen workforce capacity for One Health implementation globally. The Taskforce will coordinate training across human, animal, plant, and environment health sectors, leveraging existing learning platforms from all three organizations.

Routine Notice Public Health
WHO News
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First-Ever WHO Forum Unites 800+ Collaborating Centres for Scientific Collaboration

The World Health Organization convened the first Global Forum of Collaborating Centres in Lyon, France, bringing together over 800 institutions from more than 80 countries. The forum announced the creation of Collaborative Open Research Consortia to accelerate development of vaccines, diagnostics, and treatments for Disease X. Participants emphasized that international cooperation and collective investment remain critical amid reductions in global health financing.

Routine Notice Public Health
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Agency Information Collection Activities: Proposed Collection; Comment Request

CMS published a Federal Register notice on April 10, 2026, requesting public comments on a proposed information collection activity under the Paperwork Reduction Act. The notice opens a 60-day comment period closing June 9, 2026. Healthcare providers and organizations that submit information to CMS may be indirectly affected by any new or modified reporting requirements that result from this collection activity.

Routine Notice Healthcare
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CMS PRA Comment Request: Agency Information Collection Activities

CMS published a Paperwork Reduction Act notice seeking public comments on proposed information collection activities related to agency programs. The notice invites feedback on the burden estimates, data collection methods, and necessity of the proposed information collections. Comments are due within 60 days of publication.

Routine Notice Healthcare
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USDA Removes Horse Import Pre-Export Examination Requirement

USDA APHIS issued a final rule removing the mandatory pre-export examination requirement for horses imported into the United States. The change affects importers and exporters of horses by eliminating an examination step previously required before entry. The rule takes effect May 11, 2026.

Routine Rule Agriculture
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Council of Councils Meeting Notice, May 14-15, 2026

NIH announces a two-day Council of Councils meeting on May 14-15, 2026, in Bethesda, MD. The meeting includes open sessions covering welcome remarks, DPCPSI reports, and NIH program updates, as well as a closed session for grant application review. The closed portions will address confidential trade secrets, patentable material, and personal information related to grant applications. The public may attend open sessions via videocast or in person, and written comments may be submitted to the Contact Person.

Routine Notice Public Health
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Center for Scientific Review Notice of Closed Meetings

NIH Center for Scientific Review announces five closed meetings scheduled for May 7, 2026 to review grant applications. Meetings are closed under Federal Advisory Committee Act provisions because discussions could disclose confidential trade secrets, patentable material, and personal information of applicants.

Routine Notice Healthcare
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Center for Scientific Review Notice of Closed Meetings

The NIH Center for Scientific Review published a notice announcing five closed meetings scheduled for May 5-7, 2026, to review and evaluate grant applications for mentored training, cancer research, infertility technologies, and research excellence awards. The meetings will be held virtually and closed to the public under Federal Advisory Committee Act exemptions to protect confidential trade secrets, commercial property, and personal information associated with grant applications.

Routine Notice Healthcare
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Petition Submission Information Collection: Food Additive, Color Additive, Master File, Form 3503

The FDA published a notice announcing a 60-day public comment period on proposed information collection requirements for petition submissions under the Paperwork Reduction Act. The collection covers food additive petitions, color additive petitions including labeling, master file information submissions, and electronic submissions using FDA Form 3503. Comments must be submitted by June 9, 2026.

Routine Notice Food Safety
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Color Additive Certification Information Collection Comment Request

The FDA published a notice in the Federal Register announcing an opportunity for public comment on a proposed information collection related to color additive certification under the Paperwork Reduction Act. The notice solicits comments on the burden associated with color additive certification requirements. Comments must be submitted by June 9, 2026.

Routine Notice Food Safety
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Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices

The FDA published a notice in the Federal Register seeking public comment on a proposed information collection related to premarket approval of medical devices. The collection pertains to burden hour estimates for required submissions under the Paperwork Reduction Act. Comments are due within 60 days of the April 10, 2026 publication date.

Routine Consultation Medical Devices
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GSK Withdraws Wellcovorin NDA - Leucovorin Calcium Tablets Discontinued

FDA withdrew approval of NDA 018342 for Wellcovorin (leucovorin calcium) tablets at GSK's written request after the company notified the Agency the drug products were no longer marketed. GSK waived its opportunity for a hearing and requested withdrawal under 21 CFR 314.150(c). Existing inventory may be dispensed until depleted or until expiration dates.

Routine Notice Pharmaceuticals
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USPTO Letter to FDA CDER Regarding Patent Matters

USPTO sent a letter to FDA CDER regarding patent-related matters. The document contains limited content available for public review, with the full letter available only as an attachment. This represents routine inter-agency communication on intellectual property matters affecting pharmaceutical regulation.

Routine Notice Intellectual Property
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Letter to FDA CDER Regarding Patent Matter

USPTO transmitted correspondence to FDA CDER regarding a patent-related matter. The letter is filed under docket FDA-2026-E-3811-0001 and is accessible as a PDF attachment. Specific content details are not visible in the available document metadata.

Routine Notice Intellectual Property
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USPTO Letter to FDA CDER Regarding Patent Procedures

The USPTO transmitted correspondence to FDA's Center for Drug Evaluation and Research regarding patent-related procedures. The letter was filed in the regulatory docket on April 9, 2026. This inter-agency communication addresses administrative patent matters between the two federal agencies.

Routine Notice Intellectual Property
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USPTO Letter to FDA CDER on Patent Matters, Apr 8

USPTO sent an inter-agency letter to FDA CDER regarding patent-related matters. The communication appears in a FDA regulatory docket and addresses coordination between the two agencies on intellectual property issues. No specific regulatory requirements or compliance obligations are detailed in the available documentation.

Routine Notice Intellectual Property
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FDA Requirement for Patent Information to Clark & Elbing

FDA Requirement for Patent Information to Clark & Elbing

Routine Notice
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Letter from USPTO to FDA CDER Regarding Patent Matters

The USPTO sent correspondence to FDA's Center for Drug Evaluation and Research on April 9 regarding patent-related matters. The document is filed under docket FDA-2026-E-3821-0001 and is available only as an attachment PDF on regulations.gov.

Routine Notice Intellectual Property
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Milestone Pharma Patent Term Extension Application

FDA received a patent term extension application from Clark & Elbing LLP on behalf of Milestone Pharmaceuticals, Inc. The application seeks to extend patent protection for a drug product regulated by CDER. Patent term restoration may compensate for regulatory review time under applicable law.

Routine Notice Intellectual Property
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Milestone Pharmaceuticals Patent Term Extension Application

Clark & Elbing, LLP filed a patent term extension application on behalf of Milestone Pharmaceuticals, Inc. with the FDA's Center for Drug Evaluation and Research (CDER). The application seeks to extend patent protection for a pharmaceutical product to compensate for regulatory review time. Patent term extensions under 35 U.S.C. 156 can extend patent terms by up to 5 years.

Routine Notice Intellectual Property
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USPTO Letter to FDA CDER on Patent Matters

The USPTO sent a letter to FDA's Center for Drug Evaluation and Research on April 9, 2026, regarding patent-related matters. The correspondence appears to address inter-agency coordination on pharmaceutical patent issues. No documents are available for public viewing in the regulatory docket.

Routine Notice Intellectual Property
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Cook Medical Recalls Sizing Catheters Due to Marker Band Cracking Risk

FDA issued an early alert notifying healthcare providers that Cook Medical's Centimeter, Aurous Centimeter, and Beacon Tip Centimeter Sizing Catheters may have marker bands at increased risk of cracking or breakage. Potential adverse events include increased procedural time, device fragmentation, vessel injury, and life-threatening harm or death in worst-case scenarios. Healthcare providers should immediately stop using affected devices and return them to Cook Medical.

Urgent Enforcement Medical Devices
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Baxter Volara Single-Patient Use Circuits - Updated Instructions, Class I Recall

FDA announced a Class I recall correction for Baxter Volara single-patient use ventilator circuits after reports of oxygen desaturation and barotrauma risks. The affected Blue Ventilator Adaptor Module (Product Code M07937) may cause serious injury or death when used in-line with home care ventilators without following updated instructions. Baxter is notifying affected customers and providing clinical support including in-home training visits.

Urgent Enforcement Medical Devices
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Medline Recalls Namic Angiographic Syringes Over Unwinding Risk

Medline Industries issued an urgent medical device recall for Namic Angiographic Rotating Adaptor (RA) Control Syringes and Convenience Kits after identifying that the syringe rotating adaptor may unwind during use, causing loose connections or full disconnection from the manifold. The FDA has classified this as the most serious recall type due to the risk of biohazard exposure, blood loss, infection, air embolism, serious injury, or death. Four serious injuries have been reported as of March 13.

Urgent Enforcement Medical Devices
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Adagrasib mTOR Inhibitor Combination Cancer Treatment

USPTO published patent application US20260097038A1 by Mirati Therapeutics covering combination therapies using Adagrasib (KRas G12C inhibitor) with mTOR inhibitors for treating KRas G12C mutant cancers. The application discloses methods of treatment, pharmaceutical compositions, and kits comprising therapeutically effective amounts of both inhibitors.

Routine Notice Intellectual Property
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Prostate Cancer Combination Therapy, Abiraterone Acetate, Niraparib

USPTO published patent application US20260097048A1 for a combination therapy of abiraterone acetate and niraparib for treating prostate cancer. The application was filed on December 11, 2025, by inventors Thomas Ronald A. Quinten and colleagues, covering free-dose and fixed-dose combinations and methods of treatment.

Routine Notice Intellectual Property
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N-Acetyl Leucine Treats Niemann-Pick Disease Type C with NPC1 Mutations

The USPTO published patent application US20260097008A1 by inventor Michael Strupp covering methods of treating Niemann-Pick Disease Type C (NPC) or neurological symptoms thereof by administering N-acetyl leucine to subjects carrying NPC1 mutations. The application (No. 19352209) was filed October 7, 2025, and published April 9, 2026.

Routine Notice Intellectual Property
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Ketamine and NAP patent for ADNP syndrome treatment

Ketamine and NAP patent for ADNP syndrome treatment

Routine Notice
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Compositions and Methods for Activating GLP-1 Secretion via Nutritional Supplements

USPTO published patent application US20260096587A1 for nutritional supplement compositions designed to activate GLP-1 peptide secretion to regulate blood sugar, weight, and hunger. The application covers formulations combining hydrolyzed yeast, acacia gum, citrus bioflavonoids, cinnamon bark, MCTs, resistant starches, and botanical extracts, with disclosed efficacy of up to 200% increase in GLP-1 production. Inventors include Elisa Diane Barnes, Christina Beer, Clinton T. Horton, and Robert A. Carr.

Routine Notice Intellectual Property
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Methods Of Treating Fabry Patients Having Renal Impairment

USPTO published patent application US20260097027A1 by Amicus Therapeutics Inc. covering methods of treating Fabry disease in patients with renal impairment. The application claims administering migalastat hydrochloride at about 150 mg every other day to patients with HEK assay amenable mutations in α-galactosidase A.

Routine Notice Intellectual Property
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Pharmaceutical Composition Comprising Enavogliflozin for Cardiovascular Aging Diseases

The USPTO published patent application US20260097060A1 for a pharmaceutical composition comprising enavogliflozin as an active ingredient for preventing or treating cardiovascular aging diseases. The invention demonstrates effects in preventing endothelial dysfunction caused by vascular endothelial senescence. The application was filed on September 27, 2023, under Application No. 19115424.

Priority review Rule Intellectual Property
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Mapping and Modification of Gene Network Endophenotypes

The USPTO published patent application US20260100246A1 by Inari Agriculture Technology, Inc., disclosing a machine learning method for predicting endophenotypes of interacting partner genes. The method partitions endophenotype profiles into two sets, modifies one set to a desired level, and uses a trained ML model to predict resulting changes in the unmodified set. The invention enables targeted modification of gene networks to achieve desired agricultural traits.

Routine Notice Intellectual Property
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M13 Phage Engineered to Capture SARS-CoV-2 Virus

M13 Phage Engineered to Capture SARS-CoV-2 Virus

Routine Notice
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Novel Oral Cannabinoid CBD Formulations Patent Application

USPTO published patent application US20260097052A1 for novel oral CBD formulations by five inventors including Hardin Matthew Jackson et al. The application covers solid oral dosage forms comprising the non-psychoactive cannabinoid CBD and methods of manufacture for treating diseases.

Routine Notice Intellectual Property
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SYK Patent: Neurodegenerative Disease Treatment Methods

USPTO published patent application US20260097056A1 disclosing SYK activators and inhibitors for treating neurodegenerative diseases. The application covers specific compounds and methods for disease treatment. Inventors: John R. Lukens, Hannah Elizabeth Ennerfelt, Elizabeth Frost. Filed September 20, 2023.

Routine Notice Intellectual Property
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Combination of Zibotentan and Dapagliflozin for Treatment of Chronic Kidney Disease and Liver Fibrosis

USPTO published patent application US20260097057A1 covering fixed-dose combination therapy using zibotentan and dapagliflozin for treating chronic kidney disease and liver fibrosis. The application, filed October 8, 2025, names Philip Ambery as inventor and discloses methods of treatment using the combination.

Routine Notice Intellectual Property
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Azithromycin Premix Formulation and Product Patent Application

USPTO published patent application US20260097061A1 for an aseptically prepared azithromycin premix formulation with pH 5.5-7.5, buffering agents, and stability at refrigerated temperatures for up to 24 months. The invention covers ready-to-use aqueous solutions for IV administration that require no terminal sterilization or dilution.

Routine Notice Intellectual Property
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PD-1 Monoclonal Antibody Patent Application for Cancer Treatment

The USPTO published patent application US20260098092A1 for monoclonal antibodies targeting human programmed cell death protein 1 (PD-1) and methods for treating cancer using said antibodies and antigen-binding fragments. The application was filed October 4, 2023, naming seven inventors including Trairak Pisitkun and colleagues. Pharmaceutical and biotech companies developing PD-1/PD-L1 pathway cancer immunotherapies should monitor for this application's progression to grant.

Routine Notice Intellectual Property
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Novel Anti-Asporin Antibody Targets Fibrotic Disease Including Idiopathic Pulmonary Fibrosis

USPTO published patent application US20260098083A1 disclosing a novel antibody binding specifically to Asporin protein for predicting onset and treating fibrotic diseases, including idiopathic pulmonary fibrosis. Inventors are Hogeun Yoon and Soo-Yeon Park. The application was filed on September 20, 2023.

Routine Notice Intellectual Property
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Immunogenic Compositions for SARS-CoV-2 Vaccines Using MHC Class II Peptides

USPTO published patent application US20260097115A1 for immunogenic compositions containing MHC class II-binding peptides derived from SARS-CoV-2 translation products. The application covers vaccine compositions and methods for treating and preventing COVID-19. Inventors include researchers from Broad Institute and affiliated institutions.

Routine Notice Intellectual Property
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Anti-C5 Antibody, C5 iRNA Dosing Regimens, Complement Diseases

Anti-C5 Antibody, C5 iRNA Dosing Regimens, Complement Diseases

Routine Notice
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Anti-TMPRSS6 Monoclonal Antibodies and Therapeutic Uses

USPTO published patent application US20260098084A1 disclosing fully human anti-TMPRSS6 monoclonal antibodies for treating diseases associated with TMPRSS6. Inventors include Harvey Chin, Sarah J. Hatsell, Heinrich Emil Lob, Andrew J. Murphy, William Olson, Kei Saotome, and Bojie Zhang, with application number 19323318 filed September 9, 2025.

Routine Rule Intellectual Property
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TACI Antibody and Use Thereof for Detecting Free Drug Levels

The USPTO published patent application US20260098866A1 covering a human TACI (B lymphocyte stimulator receptor) antibody with high specificity and affinity, along with methods for detecting free TACI or TACI-Fc fusion protein drug levels in patients. The invention enables monitoring of drug absorption and therapeutic efficacy in patients with autoimmune diseases.

Routine Rule Intellectual Property
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Composition Improves Salt Tolerance in Plants

Composition Improves Salt Tolerance in Plants

Routine Notice
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Surface-Modified Viral Particles and Modular Viral Particles Patent Application

USPTO published patent application US20260098280A1 for surface-modified viral particles and modular viral particles (anellovectors and anelloVLPs) filed December 8, 2025. The application names five inventors including Simon Delagrave, Kurt Adam Swanson, and Noah Robert Cohen. CPC classifications include C12N 15/86 and C07K 14/005.

Routine Notice Intellectual Property
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NAVROGEN Fc-Engineered Monoclonal Antibodies Targeting ICAM-1/CD54 for Cancer Treatment

USPTO published patent application US20260098858A1 for NAVROGEN, INC. covering Fc-engineered monoclonal antibodies with CH3 region modifications designed to reduce ICAM-1/CD54 binding, improving immune-effector activity and antibody drug conjugate killing for cancer and inflammatory disease treatment.

Routine Notice Intellectual Property
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Methods for Rule-based Genome Design

USPTO published patent application US20260100251A1 for computer-implemented methods of rule-based genome design. The application covers systems receiving known genome data and allele lists, generating alternative gene sequences, and scoring each sequence using a weighted combination of multiple rules, constraints, or parameters. Inventors include George M. Church and Nili Ostrov.

Routine Notice Intellectual Property
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Rifabutin Analogs for Treatment of M. abscessus Bacterial Infections

USPTO published patent application US20260098046A1 for new rifabutin analog compounds and pharmaceutical compositions for treating bacterial infections, with particular focus on non-tuberculous mycobacteria including M. abscessus. The application was filed on September 29, 2023 by a team of nine inventors. This is a published patent application, not a granted patent.

Routine Notice Intellectual Property
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Anti-Giardial Heterocyclic Compounds for Parasitic Infections

USPTO published patent application US20260098047A1 covering heterocyclic compounds of Formula (I) and (II) for treatment and prevention of Giardiasis (parasitic infection). The application names four inventors and includes pharmaceutical composition claims and methods of using the compounds.

Routine Notice Intellectual Property
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Improved Process for Preparing Risdiplam and Its Intermediates

The USPTO published patent application US20260098048A1 for an improved chemical synthesis process for Risdiplam, a pharmaceutical compound used to treat spinal muscular atrophy. The application also discloses novel intermediates involved in the preparation process. This is a routine patent publication that does not create immediate compliance obligations.

Routine Notice Intellectual Property
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Light-Emitting Heterocyclic Compound for Electronic Devices

USPTO published patent application US20260101670A1 for a heterocyclic compound (Formula 1) for use in light-emitting devices and electronic apparatus. The compound is incorporated into the interlayer and emission layer between electrodes. Inventors: Hwasook Ryu, Hankyu Pak, Dongjun Kim, Chaeyeong Kim, Sanghyun Han. Filing date: March 24, 2025.

Routine Notice Intellectual Property
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Nonlinear Optical Chromophores with High Steric Hinderance Substituents for Electro-Optic Devices

Lightwave Logic, Inc. published patent application US20260098206A1 covering nonlinear optical (NLO) chromophores with donors having high steric hindrance substituents, compositions/materials comprising such chromophores, and methods of making and using them in electro-optic devices. The application includes methods of drying and poling, and uses in EOMs. Inventors: Ginelle A. Ramann, Barry L. Johnson, Harvey F. Fulo, Will D. Mikkelsen-Yi.

Routine Notice Intellectual Property
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KRAS Modulating Compounds

USPTO published patent application US20260098049A1 for KRAS modulating compounds useful as KRAS inhibitors. The application covers compounds, methods of making and using them, and pharmaceutical compositions. Filed August 11, 2025, with 19 inventors listed.

Routine Notice Intellectual Property
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Lightwave Logic NLO Chromophores 3-Aminocyclohex-2-en-1-one Donor Groups

USPTO published patent application US20260099078A1 by Lightwave Logic, Inc. for nonlinear optical chromophores containing 3-aminocyclohex-2-en-1-one based donor groups. The application covers compositions, materials, and resistive layers comprising these NLO chromophores, methods of making and using them including drying and poling processes, and applications in electro-optic devices such as electro-optic modulators.

Routine Notice Intellectual Property
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Crystalline Form Patent, Tetracyclic Carboxamide, Apr 09

Crystalline Form Patent, Tetracyclic Carboxamide, Apr 09

Routine Notice
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HHS Proposed Rule Comment Submission Form

HHS is accepting public comments on a proposed rule through Regulations.gov. The submission form enables commenters to provide feedback up to 5,000 characters and attach supporting files, with the comment period closing May 8, 2025.

Routine Notice Healthcare
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Nasal Cannabidiol Composition Patent, Frank-Markus Leweke, Apr 9

Nasal Cannabidiol Composition Patent, Frank-Markus Leweke, Apr 9

Routine Notice
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Cannabichromene COVID-19 ARDS Treatment Patent Application

The USPTO published patent application US20260097051A1 from Augusta University Research Institute claiming compositions comprising Cannabichromene (CBC) for treating COVID-19 ARDS. The application was filed August 18, 2025 and published April 9, 2026.

Routine Notice Intellectual Property
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Anti-CCR8 Antibodies Therapeutic Agents Patent Application

USPTO published patent application US20260098096A1 for anti-CCR8 antigen binding proteins and fragments for detection and therapy of various conditions, including cancer. The application was filed September 21, 2023, by inventor Remy Michel Robert. CCR8 is a G-protein coupled receptor implicated in tumor immunosuppression.

Routine Notice Intellectual Property
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US20260098093A1, VISTA Molecules, Cancer Treatment, 9th Apr

US20260098093A1, VISTA Molecules, Cancer Treatment, 9th Apr

Routine Notice
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CCR8 Antibodies and Fusion Proteins for Cancer Treatment

The USPTO published patent application US20260098098A1 covering CCR8-binding antibodies and fusion proteins for cancer treatment. Inventors McGrath et al. filed Application No. 19182473 on April 17, 2025, with the application published on April 9, 2026. The patent covers therapeutic compositions and methods using CCR8-targeted biologics.

Routine Notice Intellectual Property
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Immunotoxin-Based Targeted Therapy for Cancer, CCR4 Bispecific

The USPTO published patent application US20260098097A1 for methods of treating cancer using a genetically engineered C-C motif chemokine receptor 4 (CCR4) bispecific immunotoxin. The application, filed December 29, 2023, covers treatment of cutaneous T-cell lymphoma and other cancers via administration of the immunotoxin alone or in combination with additional therapeutic agents such as antibody-drug conjugates.

Routine Notice Intellectual Property
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Multispecific Antibodies Targeting HLA-A2/MAGE-A4 Cancer Therapy

USPTO published Roche/Genentech patent application US20260098095A1 disclosing multispecific antibodies binding to HLA-A2/MAGE-A4 complex for T cell activation in cancer treatment. The application covers antibody compositions, encoding polynucleotides, production methods, and therapeutic uses. The invention addresses immunotherapy approaches for HLA-A2-positive tumors expressing MAGE-A4 antigen.

Routine Notice Pharmaceuticals
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Medline Neuro Sponges Recall - Elevated Endotoxin Risk

Health Canada issued a Type II recall for Medline Neuro Sponges (Gauze Sponges, X-Ray Detectable) due to potential out-of-specification endotoxin levels. Affected products include all lots of eight model numbers (NEUROSPNG05, 02, 13, 06, 07, 14, 09, 11). Elevated endotoxin levels may require medical or surgical intervention, though the likelihood of adverse health consequences is considered remote. Healthcare facilities must destroy recalled products immediately.

Urgent Enforcement Medical Devices
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Health Canada Warns Against Unauthorized Injectable Peptides

Health Canada issued a public advisory warning consumers about serious health risks of unauthorized injectable peptide drugs sold online. The advisory identifies 14 specific peptides including BPC-157, Melanotan, TB-500, CJC-1295, and Retatrutide that have been seized as illegal health products. These products marketed for anti-aging, bodybuilding, weight loss, or wellness lack Health Canada safety, efficacy, and quality assessment.

Priority review Notice Pharmaceuticals
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Medline ENFit G-Tube Connector Recall - Type II

Health Canada issued a Type II recall for Medline ENFit G-Tube Connectors (ENFIT1010GC) across all lots due to dimensional manufacturing defects. The non-compliant connectors may fail to form proper seals with ENFit devices, causing leakage and potentially delaying patient care during medication administration. Healthcare providers must identify and destroy affected products.

Priority review Enforcement Medical Devices