Hinova's Heterocyclic AR Degrader EP4378936A1
The European Patent Office published patent application EP4378936A1, filed by Hinova Pharmaceuticals Inc., covering bifunctional chimeric heterocyclic compounds designed to degrade androgen receptors for therapeutic use. The patent designates 31 EPO member states and classifies under C07D (heterocyclic compounds), A61K (pharmaceutical preparations), and A61P 35/00 (anticancer agents). The filing names 17 inventors and represents a pharmaceutical manufacturer's IP protection strategy for a targeted cancer therapy compound.
Organic Molecules for Optoelectronic Devices - Samsung Display EP4472973A1
The European Patent Office granted Samsung Display Co., Ltd. Patent EP4472973A1 for organic molecules used in optoelectronic devices. The patent covers compounds classified under C07D 405/14 and H10K with applications in display technology. The designation covers 31 European contracting states including major markets such as DE, FR, GB, IT, and ES.
PSMA Targeting Ligand Compound for Prostate Cancer Diagnosis and Treatment
The European Patent Office published patent application EP4431503A1 filed by Chengdu StarRay Therapeutics Co., Ltd. covering ligand compounds that target PSMA (Prostate-Specific Membrane Antigen) for use in prostate cancer diagnosis and treatment. The application includes claims for chelate compounds and their therapeutic and diagnostic applications. The patent is classified under IPC codes C07D 401/12, C07F 5/00, A61K 51/04, and A61P 35/00, covering 37 designated contracting states.
Novel PARP7 Inhibitor and Use Thereof
The European Patent Office published patent application EP4378938A1 filed by Shanghai Qilu Pharmaceutical Research and Development Centre Ltd., covering a novel PARP7 inhibitor and its therapeutic use. The application was published on April 8, 2026 under IPC classification C07D 403/10 (A61P 35/00 for anticancer indications). The designated states cover all major European Patent Convention contracting states including DE, FR, GB, IT, ES, NL, BE, CH, and others.
EP4426712A1 - Processable Compositions Patent
The European Patent Office published patent application EP4426712A1 filed by Ripple Therapeutics Corporation on April 8, 2026. The patent covers processable compositions including steroidal compounds and heterocyclic derivatives with potential therapeutic applications spanning cardiovascular treatments, glaucoma, and ocular hypertension. The designated contracting states cover all major European Economic Area nations including Germany, France, the United Kingdom, Italy, Spain, and the Netherlands.
HETEROCYCLIC COMPOUNDS AS KINASE INHIBITORS, COMPOSITIONS, AND METHODS OF USE THEREOF
The European Patent Office published patent application EP2023216237A1 for JS Innomed Holdings Ltd., covering heterocyclic compounds as kinase inhibitors, compositions, and methods of use. The A1 publication indicates the application has passed formal examination and is now open for opposition. The patent covers compounds classified under IPC C07D 471/04 with therapeutic applications in A61K 31/437 and A61P 35/00 (oncology). The designated states include all current EU member states plus associated countries.
Phenoxy and Benzyloxy Substituted Psychoplastogens and Uses Thereof
The European Patent Office published patent application EP4448531A1 for Delix Therapeutics covering phenoxy and benzyloxy substituted psychoplastogens and their therapeutic uses. The patent application lists designations across 31 European states and territories. The compounds are classified under IPC C07D 487/04 with therapeutic applications including neurological and psychiatric conditions such as anxiety, Alzheimer's disease, and addiction disorders.
Pyrimidine Tricyclic Derivative and Pharmaceutical Application (EP4417613A1)
EPO granted patent EP4417613A1 to CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. The patent covers pyrimidine tricyclic derivatives and their pharmaceutical applications. The patent is designated in multiple contracting states including DE, FR, GB, IT, ES, NL, SE, PL, and other EU member states.
Fused Benzoisoxazolyl Compounds as KAT6A Inhibitors
The European Patent Office published patent application EP4448109A1 for fused benzoisoxazolyl compounds as KAT6A inhibitors, filed jointly by Aurigene Oncology Limited and Olema Pharmaceuticals, Inc. The invention covers heterocyclic antineoplastic compounds classified under A61P 35/00 and C07D 498/04. The patent is designated for all European Patent Convention contracting states.
PIKFYVE Inhibitor Compounds Patent Application - C07D 487/04
European Patent Office published patent application EP4444316A1 for PIKFYVE inhibitor compounds and pharmaceutical compositions. The application, filed by Kineta, Inc., covers heterocyclic compounds (C07D 487/04) with therapeutic applications including neurological conditions (A61P 25/28). Inventors include Kumaravel, Macdonnell, and Peng. A1 publication indicates the application has entered the European phase and is publicly available for examination.
Tetravalent Bispecific Antibody, Preparation Method Therefor, and Use Thereof
The European Patent Office published patent application EP3967711A1 for a tetravalent bispecific antibody filed by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. The application covers the antibody's preparation method and therapeutic uses. The A1 publication includes a European search report and designates 32 member states including AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, and TR.
Orthogonal Mutations for Heterodimerization - Invenra Inc.
EPO published patent application EP4259194A1 titled 'Orthogonal Mutations for Heterodimerization' filed by Invenra Inc. The invention relates to methods for creating orthogonal mutation pairs to facilitate controlled heterodimerization of proteins, with applications in bispecific antibody development and therapeutic protein engineering. The application covers 47 designated EU member and extension states including Germany, France, UK, Italy, Spain, and other EPC contracting states.
Fate Therapeutics iPSC Effector Cells for Immunotherapy Patent EP4168538A1
The European Patent Office published patent application EP4168538A1 for Fate Therapeutics, Inc., covering methods of combining iPSC-derived effector cell types for immunotherapy use. The patent includes claims related to cell therapy compositions, cytokine combinations, and therapeutic applications for cancer treatment. The patent designation covers 31 European member states.
Modified B Cells and Methods of Use Thereof - EP4203978A1
The European Patent Office published patent application EP4203978A1 for Modified B Cells and Methods of Use Thereof, filed by Walking Fish Therapeutics, Inc. The patent covers engineered B cells for therapeutic applications, including cancer treatment indications (A61P 35/00). The application contains 18 IPC classifications spanning peptides, immunology, gene therapy vectors, and therapeutic preparations.
IL10 Receptor Binding Molecules and Methods of Use - EP4192880A2
The European Patent Office published application EP4192880A2, a patent for IL10 receptor binding molecules and methods of use, filed by Synthekine, Inc. The patent covers C07K peptide-based compounds under classifications C07K 16/28, C07K 14/715, and C07K 14/705. The application designates all EU member states and participating EPC contracting states including CH, LI, NO, TR, and MC.
ENPP1 Antibody Inhibitors - University of California
The European Patent Office published application EP4146706A1 for ENPP1 antibody inhibitors filed by The Regents of the University of California. The application claims anti-ENPP1 antibodies for therapeutic use, classified under IPC C07K 16/40, A61P 9/10, A61K 39/395, and C12N 15/63. The application designates all relevant European member states including AT, BE, DE, FR, GB, IT, NL, ES, PL, and 25 others.
EP4200339A2 - Compositions and Methods Related to Receptor Pairings
European Patent Office granted Patent EP4200339A2 to Synthekine, Inc. covering compositions and methods related to receptor pairings. The patent application, filed with IPC classifications C07K 16/28, C07K 14/715, and C07K 14/705, lists inventors KASTELEIN Robert, LUPARDUS Patrick J., and ROKKAM Deepti. The patent is designated across all European member states.
EP4146277A1 - Avian Antibodies Reduce Viral Disease Transmission
The European Patent Office granted Patent EP4146277A1 to Camas Incorporated on April 8, 2026, covering compositions and methods for using avian antibodies to reduce viral disease transmission. The patent names nine inventors and is classified under IPC categories A61K 39/42, A61P 11/00, A61P 31/12, and C07K 16/08. The patent is designated across 31 European states including Germany, France, the United Kingdom, Italy, and Spain.
Long Acting GLP-1 Receptor Agonists and Methods of Use
The European Patent Office published patent application EP4263587A1 for long-acting GLP-1 receptor agonists filed by I2O Therapeutics, Inc. The patent covers glucagon-like polypeptide-1 receptor agonist compositions and methods of use for treating metabolic disorders including obesity, hyperlipidemia, and diabetes. The patent is directed to peptide compounds classified under C07K 14/605 with designated protection across 31 European member states.
Silver Moon LP dba Loard's Ice Cream Issues Allergy Alert on Undeclared Milk, Eggs, Tree Nuts, Peanuts, Soy, Sulfites, and Colors
Silver Moon LP dba Loard's Ice Cream of San Leandro, CA voluntarily recalls all retail-sized ice cream products after FDA inspection found packaging lacked required ingredient and allergen labeling statements. Affected products contain undeclared allergens including milk, eggs, tree nuts, peanuts, soy, sulfites, and artificial colors. The products were distributed to Loard's Ice Cream parlors in Northern California. No illnesses have been reported to date.
Canine Milk Replacers Recalled for Elevated Vitamin D
Revival Animal Health of Orange City, IA voluntarily recalls Breeder's Edge Foster Care and Shelter's Choice Canine Milk Replacers due to variable levels of Vitamin D. Affected products were sold nationwide through online and retail pet stores in multiple package sizes. Two complaints of rickets have been reported to date. Consumers are advised to discontinue use and contact the company for a full refund.
House Wellness Foods Probiotic Therapeutic Patent Granted
The USPTO granted Patent US12599638B2 to House Wellness Foods Corporation for a feed and composition comprising Lactobacillus plantarum strain L-137 and a fatty acid. The patent covers compositions for enhancing IL-12 production, immunostimulation, and bacteriostasis. The patent application was filed on September 21, 2021, with 7 claims granted.
Signum Biosciences Chia Seed Extract Patent Granted
The USPTO granted patent US12599642B2 to Signum Biosciences Inc on April 14, 2026. The patent covers compositions derived from Salvia hispanica (chia) seeds and methods of preparation and administration. The 18 claims span dermatological applications including skin care and sunscreen formulations. Third parties face no compliance obligations from this patent grant.
Enzyme-Cleavable Prodrug Compositions and Controlled Release Nafamostat Methods
USPTO granted patent US12599578B2 to Ensysce Biosciences Inc. for pharmaceutical compositions including enzyme-cleavable prodrugs providing enzymatically-controlled release of active agents, combined with controlled release nafamostat. The patent covers 12 claims and methods of use for these pharmaceutical compositions.
Lipid Triglyceride Surfactant Composition, Patent US12599580B2
The USPTO granted patent US12599580B2 to BASF AS on April 14, 2026, covering compositions comprising 2-((5Z,8Z,11Z,14Z,17Z)-icosa-5,8,11,14,17-pentaenyloxy)butanoic acid, a triglyceride, and a surfactant, as well as methods of using the same in self-emulsifying drug delivery systems such as SEDDS, SMEDDS, or SNEDDS. The patent contains 20 claims.
Nanoparticle Wound Healing Treatment Patent US12599698B2
USPTO granted patent US12599698B2 to Kismet Technologies Inc. on April 14, 2026, covering a therapeutic article with metal-modified cerium oxide nanoparticles (mCNPs) for wound healing and antimicrobial infection control. The patent includes 19 claims for the nanoparticle-treated fiber composition with particles sized 3-35nm.
Axcess Global Sciences LLC Patent - Ketone Bodies and Amino Acid Compositions
The USPTO granted patent US12599579B2 to Axcess Global Sciences LLC covering compositions of ketone bodies or ketone body precursors complexed with amino acids. The patent, effective April 14, 2026, contains 22 claims and names Gary Millet, Ryan Lowery, Jacob Wilson, and Terry Lacore as inventors. The compositions are directed toward uses including weight loss, blood glucose management, muscle performance, metabolic repair, neurological treatment, and anti-aging applications.
NLRP3 Modulators for Treating Interleukin 1β Diseases
USPTO granted patent US12599616B2 to Zydus Lifesciences Limited for novel substituted sulfonylurea and sulfoximineurea derivatives as NLRP3 modulators for treating interleukin 1β-mediated diseases and conditions. The patent contains 11 claims and 20+ CPC classifications spanning A61K, C07C, C07D, and A61P therapeutic categories.
Boston Scientific Accolade Pacemaker Safety Action - Software Update SMR6
ANSM has published updated safety information regarding Boston Scientific Accolade family implantable pacemakers (Accolade, Proponent, Essentio, Altrua 2, CRT-P Visionist, and Valitude). The agency reports that Boston Scientific is deploying software update SMR6 to correct anomalies in the previous SMR5 update and prevent inappropriate triggering of safety mode. For pace-dependent patients whose devices have not been updated with SMR5 and have 4 years or less of remaining battery life, an appointment should be scheduled without delay. SMR6 may reduce battery longevity for devices with extended longevity (EL) batteries. New device packaging since March 2026 includes information about potentially reduced battery life.
MaaT013 Fecal Microbiota Allogeneic Pool Rectal Suspension Recall
ANSM and Clinigen Healthcare France have initiated a precautionary recall of six lots of MaaT013 (fecal microbiota allogeneic pool, rectal suspension). The recall follows discovery of a donor selection process non-compliance where a donor meeting exclusion criteria was included in stool collections used to manufacture the affected lots. Healthcare establishments holding affected lots (7P010/2410111, 7P010/2410092, 7P010/2410096, 7P010/2410109, 7P010/2503009, 7P010/2503012) should quarantine and return product to the manufacturer.
Patch 4 Cover FSL Sim Tatoo Adhesive Patch Recall
ANSM recorded safety action R2611097 initiated by Capteur Protect for the Patch 4 Cover FSL Sim Tatoo adhesive patch used with glucose sensors. Users of affected products received notification letters from the company. The recall affects pharmacies, retail chains, and wholesale distributors in France.
Olympus Gyrus ACMI Everest Cutting Forceps Lot Recall R2607996
ANSM registered safety action R2607996 concerning a lot withdrawal of Everest cutting forceps (pince coupante) manufactured by Olympus Gyrus ACMI. The recall was initiated by Olympus following notification to ANSM. Affected users received a direct communication from the manufacturer. This action targets hospital pharmacies and health establishments that hold the implicated lot.
Safety Notice Cryotubes Cryo.s Medical Devices by Greiner Bio-One
ANSM recorded safety action R2609958 concerning Cryotubes Cryo.s medical devices manufactured by Greiner Bio-One. The company has issued a safety communication dated 17/04/2026 to affected users. ANSM directs users to contact Greiner Bio-One directly for details and questions regarding the action.
Establishing Impurity Specifications for Antibiotics
FDA's Center for Drug Evaluation and Research (CDER) announced availability of draft guidance FDA-2025-D-6130 entitled 'Establishing Impurity Specifications for Antibiotics.' The guidance provides recommendations for establishing specifications for organic impurities in antibiotics manufactured by fermentation and semi-synthesis. Comments are being accepted via regulations.gov or mail.
Methods of Treating Locally Advanced or Metastatic Breast Cancers Using PD-1 Axis Binding Antagonists and Taxanes
The European Patent Office published patent application EP3310815A1, filed by F. Hoffmann-La Roche AG, covering methods of treating locally advanced or metastatic breast cancers using PD-1 axis binding antagonists in combination with taxanes. Inventor is Daniel S. Chen. The publication includes IPC classifications covering therapeutic antibodies, antineoplastic compositions, and designated states for national phase entry.
Two Men Charged for Running Fentanyl Lab in Residential Building
DEA New York Division Special Agent in Charge Farhana Islam announced criminal charges against two individuals for narcotics and firearms offenses related to operating an illegal fentanyl manufacturing operation in a residential building. The case involves coordination with the Department of Justice, Homeland Security Investigations, and the Southern District of New York U.S. Attorney's Office.
Microbial Consortia Patent EP3262151A1, Amvac Chemical Corporation
The European Patent Office published patent application EP3262151A1 titled 'Microbial Consortia' filed by Amvac Chemical Corporation. The patent relates to compositions and methods involving microbial consortia, classified under IPC C12N (microorganisms, fungi, algae), C05F (fertilizers), and A01N (biocides). The patent application designates all EU member states.
Helix Biopharma Corp. Antibody-Urease Conjugates for Diagnostic and Therapeutic Use
The European Patent Office granted Patent EP2984170A1 to Helix Biopharma Corp. for antibody-urease conjugates for diagnostic and therapeutic purposes. The patent, with inventor Chao Heman, covers compositions classified under A61K 47/68, A61P 35/00, C07K 16/32, C12N 9/80, and C12N 9/96. The designated states include all EU member states and extension countries.
Plants Comprising Wheat G-Type Cytoplasmic Male Sterility Restorer Genes, Molecular Markers and Uses Thereof
The European Patent Office granted BASF SE Patent EP3429334A1 covering wheat plants comprising G-type cytoplasmic male sterility restorer genes and associated molecular markers. The patent is classified under IPC codes A01H, C12N, and C07K, covering biotechnology applications for plant genetics. The designation includes 31 states across the EU and beyond.
BASF SE Patents Wheat G-Type Cytoplasmic Male Sterility Restorer Genes
The European Patent Office published patent application EP3429335A1 on April 8, 2026, granting BASF SE exclusive rights to wheat G-type cytoplasmic male sterility restorer genes, molecular markers, and related uses. The patent covers biotechnology applications in plant breeding under IPC classifications C12Q, C07K, C12N, and A01H across all designated EPO member states.
Use of Cellulase to Improve Viscosity Control of Dissolving Pulp
The European Patent Office published patent application EP3365493A1 by Novozymes A/S for the use of cellulase enzymes to improve viscosity control of dissolving pulp. The patent covers methods of treating pulp with cellulase to achieve desired viscosity characteristics in paper manufacturing processes. The application was published April 8, 2026.
City of Hope Patents Phosphorothioated Oligodeoxynucleotide Compounds and Compositions
The European Patent Office published patent application EP3316894A1 for City of Hope covering phosphorothioated oligodeoxynucleotide compounds and pharmaceutical compositions for therapeutic use. The application classifies under IPC codes C12N 15/113 and A61K 31/713 relating to oligonucleotides and nucleic acid preparations. The publication establishes a priority date and makes the application available for opposition.
DNA Editing Using Single-Stranded DNA - EP3303585A1 Patent Grant
The European Patent Office published patent grant EP3303585A1 for DNA editing using single-stranded DNA. The patent names Board of Regents of the University of Nebraska and Tokai University Educational System as applicants. The invention covers biotechnology methods for DNA editing with applications in genetic research and development.
Microbial Consortia Patent Application EP3262152A1
The European Patent Office published patent application EP3262152A1 for Amvac Chemical Corporation, covering microbial consortia compositions and their applications in agriculture and chemical processing. The patent application includes claims for biological preparations, organic fertilizers, and related compositions. The designated states cover most European countries including DE, FR, GB, ES, IT, NL, and others.
Modified Adeno-Associated Virus Capsid Patent EP4389880A1
The European Patent Office published patent application EP4389880A1 for Joint Stock Company Biocad, covering methods of obtaining modified adeno-associated virus (AAV) capsids. The patent is classified under IPC codes C12N 7/00, C12N 15/86, C07K 14/005, and others related to viral vectors and genetic engineering. The patent designates all relevant European contracting states including Germany, France, Italy, Spain, and the United Kingdom.
Anti-HER3 Antibody Drug Conjugate Patent by Beijing Sinotau Bio-Pharma
EPO published patent application EP4355787A1 for Anti-HER3 antibody drug conjugate compositions and methods by Beijing Sinotau Bio-Pharmaceuticals Technology Co., Ltd. The patent covers ADC technology targeting HER3 for cancer treatment with designated states spanning major European jurisdictions. Inventors include Zhong Xiaoyan, Li Zhe, and Zhu Jie.
Over 30,000 Illegal Vaping Goods Seized in Major TGA Operation, South-West Sydney
The TGA, assisted by NSW Police Force, seized over 30,000 illegal vaping goods from sites in Chipping Norton and Casula on 15 April 2026, with an estimated street value of $1.8 million. This enforcement action follows a significant investigation into unlawful online advertising, supply, and possession of commercial quantities of illegal vaping goods. The TGA warns that non-compliance with vaping offences under the Therapeutic Goods Act 1989 can result in penalties including up to 7 years imprisonment, or fines of up to $2.31 million for individuals and $23.1 million for corporations per offence.
Three Victorians Arrested, $2M Steroids and Peptides Seized in Joint ABF-TGA Operation
The Australian Border Force and Therapeutic Goods Administration announced the arrest of three Victorians and seizure of over $2 million worth of Performance and Image Enhancing Drugs (PIEDs), including more than 10,000 vials and 600 tablets of steroids and peptide products. The eight-month joint investigation, which began in August 2025 following the interception of 640 vials, led to criminal charges against three individuals for importing Tier 1 Goods (PIEDs). The TGA warned that unapproved peptide products present serious safety risks including contamination, infection, and tissue damage.
Study Data Technical Conformance Guide Technical Specifications Document
FDA issued technical specifications for study data conformance to guide sponsors and applicants on formatting study data submissions for drug and biologics regulatory review. The guidance applies to regulated product submissions under FDA jurisdiction. It represents current FDA thinking on technical data standards without creating new legal obligations.
Schlechter Farms Inc CGMP Food Violations Salem Oregon
Schlechter Farms Inc CGMP Food Violations Salem Oregon
House Falls in Marine Terminals Standard Revocation
OSHA has finalized the revocation of the House Falls in Marine Terminals Standard (29 CFR 1917), removing a specific fall protection requirement that applied to marine terminal operations. The final rule took effect on April 17, 2026. This action eliminates the dedicated fall prevention standard for house falls at marine terminals, though employers may still have general safety obligations under the Occupational Safety and Health Act's general duty clause.
Importer of Controlled Substances Application: LTS Therapy Systems LLC
The DEA published a notice announcing that LTS Therapy Systems LLC has applied to be registered as an importer of controlled substances. The notice opens a 31-day public comment period ending May 18, 2026, during which interested parties may file objections to the application. This is a routine administrative notice regarding a registration application under the Controlled Substances Act.
Quagen Pharmaceuticals LLC Seeks DEA Registration as Importer of Controlled Substances
DEA published notice that Quagen Pharmaceuticals LLC has applied for registration as an importer of controlled substances under the Controlled Substances Act. The notice opens a 31-day public comment period ending May 18, 2026. This is a routine administrative filing providing public notice of the application; no immediate compliance obligations are created.
Royal Emerald Pharmaceuticals Controlled Substances Importer Registration
The Drug Enforcement Administration published a notice of application by Royal Emerald Pharmaceuticals for registration as an importer of controlled substances. The notice invites public comment on the application for 31 days from the publication date. Under 21 U.S.C. 957, applicants must demonstrate compliance with registration requirements before obtaining authority to import controlled substances.
Bulk Manufacturer of Controlled Substances Application: Usona Institute, Inc.
The DEA published a notice announcing Usona Institute, Inc.'s application to register as a bulk manufacturer of Schedule I controlled substances. The notice opens a 60-day public comment period, ending June 16, 2026, during which interested parties may submit comments on the application. This is a standard registration application notice under 21 CFR Parts 1301 and 1315.
Radioactive Drug Research Committees Information Collection
The FDA is soliciting public comments on an extension of existing information collection requirements related to Radioactive Drug Research Committees under 21 CFR 361.1. Under the Paperwork Reduction Act, the Agency must publish notice and allow 60 days for public comment before submitting the collection to OMB for approval. Comments are being sought on whether the proposed collection of information is necessary for proper FDA functions.
Authorization of Emergency Use for Four Animal Drugs for Treatment of New World Screwworm
FDA announced the issuance of four Emergency Use Authorizations (EUAs) for animal drugs to treat New World screwworm infestations in livestock and companion animals. Three EUAs were issued to Boehringer Ingelheim Animal Health USA for prevention and treatment in cattle, dogs, and cats. One EUA was issued to Health and Hygiene (Pty) Ltd. for use in cattle, horses, sheep, goats, deer, birds, and captive wild mammals. The EUAs were effective on February 5, February 18, and March 10, 2026, following an August 2025 HHS determination of significant public health emergency potential.
Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
The FDA is announcing an opportunity for public comment on a proposed extension of its generic clearance for qualitative data collection. The collection supports social and behavioral research for food, dietary supplements, cosmetics, and animal food and feed. Under the Paperwork Reduction Act, the Agency must publish a 60-day notice and allow public comment before submitting the collection to OMB. Comments are due by June 16, 2026.
Animal Drug User Fee Act; Public Meeting; Request for Comments
The FDA announced a virtual public meeting on the Animal Drug User Fee Act (ADUFA) reauthorization process. The meeting will be held May 27, 2026, from 2 p.m. to 4 p.m. Eastern Time. The docket will remain open for comments until December 1, 2027, with comments suggesting program changes due by July 1, 2026 for publication on the FDA website.
Animal Generic Drug User Fee Act Public Meeting Request for Comments
The FDA announced a virtual public meeting on May 27, 2026 (11 a.m. to 1 p.m. ET) to gather stakeholder input on the Animal Generic Drug User Fee Act (AGDUFA) reauthorization. The docket (FDA-2011-N-0655) will remain open for comments through December 1, 2027, with comments for website publication due by July 1, 2026. This notice solicits feedback from the generic animal drug industry on program improvements.
Stability Testing for Medicated Premixes Draft Guidance
FDA's Center for Veterinary Medicine (CVM) published draft guidance revising VICH GL8(R), updating stability testing requirements for medicated premixes used in veterinary medicine. The document is open for public comment through June 15. This guidance aligns U.S. requirements with international VICH harmonized standards for veterinary pharmaceutical products.
Stability Testing Medicated Premixes Draft Guidance
FDA has issued draft guidance on stability testing requirements for medicated premixes, opening a public comment period. The guidance applies to veterinary pharmaceutical manufacturers producing medicated feed premixes. Interested parties may submit comments through Regulations.gov. The docket number is FDA-2021-D-0613-0003.
FDA CTP Complaint Filed April 16, 2026
FDA's Center for Tobacco Products (CTP) filed a complaint on April 16, 2026, initiating formal enforcement proceedings against undisclosed parties for alleged violations of tobacco regulations under the Federal Food, Drug, and Cosmetic Act. The complaint, docketed as FDA-2026-H-3940-0001, is available on Regulations.gov with supporting documentation. This enforcement action may result in civil penalties, injunctive relief, or other remedies as determined through the administrative or judicial process.
UNLOXCYT Regulatory Review Period; Comment by Jun 15
UNLOXCYT Regulatory Review Period; Comment by Jun 15
UNLOXCYT Patent Extension Determination Comment Period
FDA has opened a public comment period regarding the patent extension determination for UNLOXCYT (a pharmaceutical drug product). Stakeholders may submit comments through the Regulations.gov portal. The comment form collects commenter identity, email address for confirmation, and optional attachments up to 20 files.
P210016 Safety Effectiveness Summary
FDA issued a Final Order for Premarket Approval P210016, including a Safety Effectiveness Summary for the Class III medical device. This order completes the FDA premarket approval review process, authorizing the device for market entry based on demonstrated safety and effectiveness data. The order applies to the device manufacturer holding PMA P210016.
P230025 Safety Effectiveness Data Summary
FDA issued a Final Order for Premarket Approval application P230025, summarizing the safety and effectiveness data reviewed for the medical device. The order documents FDA's determination that the device meets approval standards based on clinical and bench testing data submitted by the sponsor. This final order concludes the premarket review process for the device.
FDA Reclassifies Non-Invasive Bone Growth Stimulators to Class II
FDA issued a final order reclassifying non-invasive bone growth stimulators (product codes LOF and LPQ) from class III to class II, subject to premarket notification (510(k)) and special controls. The devices, previously requiring premarket approval (PMA), are now subject to the less burdensome 510(k) pathway. The reclassification is effective May 18, 2026.
Tumor Stroma Imaging Agent with FAP Targeting
USPTO granted patent US12599685B2 to Shanghai University of Medicine & Health Sciences for a tumor stroma imaging agent targeting fibroblast activation protein (FAP). The imaging agent exhibits high affinity for FAP, high uptake for malignant tumors with high FAP expression, and high sensitivity and specificity for tumor diagnosis. The patent covers the chemical structure where R is hydrogen or fluorine, and claims the agent's use for malignant tumor diagnosis and treatment with prolonged half-life.
Antibody for Binding to Interleukin 4 Receptor
USPTO granted Patent US12600771B2 to Connect Biopharma Hong Kong Limited for an antibody capable of binding to the interleukin 4 (IL-4) receptor. The patent covers the antibody itself, encoding nucleic acids, vectors, host cells, production methods, medical uses, and kits. The patent contains 30 claims and was filed on November 15, 2023.
Megmilk Snow Brand - US12599639B2 Joint Function-Improving Composition Patent
USPTO granted patent US12599639B2 to MEGMILK SNOW BRAND CO., LTD. for a joint function-improving composition containing bacterial cells and/or cultures of Lactobacillus, Lactococcus, Streptococcus, or Bifidobacterium genera combined with a joint function-improving agent. The composition targets prevention or treatment of osteoarthritis and rheumatoid arthritis through chondrocyte growth promotion and suppression of inflammation, cartilage degradation, pain, and neuronal outgrowth factors. The patent covers food, drink, feed, and pharmaceutical applications.
Serum Exosome With High Osteogenesis and High Angiogenesis for Bone Defect Repair
USPTO granted Patent US12599630B2 to Peking University School and Hospital of Stomatology for a serum exosome composition with high osteogenesis and high angiogenesis for bone defect repair. The patent covers exosomes derived from serum during fracture recovery period (weeks 2-5 post-fracture) and methods of preparing and using them for bone defect repair. The patent contains 5 claims.
CAR T Cell Therapy Patent - US12600775B2
USPTO granted Patent US12600775B2 to Kite Pharma, Inc. for methods of preparing, producing, processing, culturing, isolating, or making cells suitable for immune or cell therapy and their use in cell therapy. The patent covers CAR T cell therapy methods with applications in cancer treatment.
Chimeric Antigen Receptors Targeting CD79B and CD19 for Cancer Treatment
USPTO granted Patent US12600760B2 to The General Hospital Corporation on April 14, 2026, covering chimeric antigen receptors (CARs) targeting CD79B and CD19 for cancer treatment. The patent includes methods for producing T cells with CARs having extracellular domains that bind both CD79b and CD19. Invented by Marcela V. Maus, the patent covers upfront treatment methods where the patient has not been previously treated for the cancer.
Treatments for Ocular Neovascularization
USPTO granted patent US12599680B1 to 4D Molecular Therapeutics Inc. covering compositions and methods for treating ocular neovascular diseases such as wet age-related macular degeneration. The patent contains 24 claims and expires August 14, 2045.
Evaluation of the PATH Program—Reinstatement of Information Collection
SAMHSA published a notice announcing the reinstatement of information collection activities for the Evaluation of the Projects for Assistance in Transition From Homelessness (PATH) Program. The notice requests public comments on proposed data collection instruments including a State PATH Contact (SPC) Web Survey (reduced from 82 to 49 questions) and Site Visit Discussion Guides. The estimated total burden is 578.5 hours across 361 respondents with a total hour cost of $15,896.39. Comments are due within 60 days of publication.
Early Alert: American Contract Systems Coronary Angio Pack Convenience Kits with Affected Namic RA Syringes
FDA's Center for Devices and Radiological Health (CDRH) issued an Early Alert for American Contract Systems Coronary Angio Pack convenience kits (ANCA80AQ, ANCA80AP) containing Namic Angiographic Control Syringes with Rotating Adaptor subject to Medline's recall. The syringes' rotating adaptor may unwind during use, causing loose connections or disconnection between syringe and manifold. This poses risks of biohazard exposure, blood loss, infection, air embolism, serious injury, or death. Four serious injuries have been reported as of March 13.
Phosphoantigen Prodrug Compounds
The European Patent Office granted patent EP3818064A1 for phosphoantigen prodrug compounds to University College Cardiff Consultants Ltd. and University of Birmingham. The patent covers novel chemical compounds with applications in immunology and oncology, classified under IPC C07F 9/44 and A61K 31/664. The patent is valid in 44 designated contracting states across Europe.
PD-1 Antibodies, Nanjing Legend Biotech, 8th Apr
PD-1 Antibodies, Nanjing Legend Biotech, 8th Apr
TNF Inhibitor for Gastrointestinal Disease Treatment, EP3810095A1
The EPO published patent application EP3810095A1 for BT Bidco, Inc., covering a TNF inhibitor formulation for treating gastrointestinal diseases. The patent application was published under IPC classifications A61K 9/22, A61K 31/436, and A61K 48/00. The application designates all EU member states plus other EPC contracting states including CH, GB, LI, MC, NO, TR, and IS.
Hydrocortisone for Treatment of Mastitis in Non-Human Mammals, EP3829591A1
The European Patent Office published Patent Application EP3829591A1 for VIRBAC covering hydrocortisone formulations for treating mastitis in non-human mammals. The application names inventors HAVRILECK Bertrand, JASMIN Pierre, and MCGAHIE David with IPC classifications in A61K therapeutic preparations. The designated states cover EU contracting states including AT, BE, DE, ES, FR, GB, IT, NL, PL, and others.
Compounds, Compositions, Methods, and Uses for Treating Cancer and Immunological Disorders
The European Patent Office granted Patent EP3820533A2 to IL-2RX, Inc. covering novel compounds and compositions for treating cancer and immunological disorders. The patent application, filed by inventors Soares and Hurt, was published April 8, 2026 under IPC classifications A61K 47/64, A61K 47/65, A61P 35/00, and A61P 37/02. The patent is designated for all EU member states and extended territories.
Thiocycloheptyne Derivatives and Their Use
The EPO published European patent application EP3820858A1 for thiocycloheptyne derivatives and their pharmaceutical use, filed by Cristal Delivery B.V. The patent covers thiocycloheptyne compound compositions and their therapeutic applications under IPC classification A61K. The patent is validated in all designated EU contracting states including Germany, France, the United Kingdom, Italy, Spain, and 24 other jurisdictions.
FDA Encourages Sponsors to Pursue New Testosterone Therapy Indication for Low Libido
The FDA announced it is taking an initial step to expand treatment options for men with low libido by encouraging sponsors of approved testosterone replacement therapy (TRT) products to express interest in pursuing a potential new indication for idiopathic hypogonadism. Following a preliminary review of published clinical literature and a December 2025 expert panel discussion, FDA identified data suggesting TRT may be safe and effective for certain men with low libido related to low testosterone without an identifiable cause.
Philips Ingenia and Achieva MRI Systems - MRE Liver Stiffness Measurement Recall
Health Canada has issued a Type I recall for Philips Ingenia and Achieva MRI Systems following identification of two software issues affecting diagnostic accuracy. The primary issue involves MRE (Magnetic Resonance Elastography) stiffness measurements where default scan protocol voxel size settings are too small, potentially producing inaccurate (lower) liver stiffness values. A secondary issue affects Philips Vue Motion v12.2.0-v12.2.8.500 where mis-ordered image frames during dynamic cine runs may display out of sequence. Affected products include multiple Ingenia and Achieva 3.0T models with specific lot numbers.