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Official announcements from FDA and WHO — public domain content, updated continuously.

FDA 3d ago ↗
FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk
FDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack.
FDA 7d ago ↗
FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma
The U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherap
FDA 11d ago ↗
FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality
The U.S. Food and Drug Administration today issued final guidance for manufacturers of cellular and gene therapy (CGT) products to implement a comprehensive, science- and risk-based plan for making sure their products meet potency standards.
FDA 13d ago ↗
FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis
The U.S. Food and Drug Administration today granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for treatment of adults with recurrent respiratory papillomatosis (RRP).
FDA 22d ago ↗
FDA Launches New Program to Advance Neuroscience Medical Product Development
FDA announces the launch of the Neuroscience Advancement and Innovation Nexus (NAIN), a new agency program aligned with the Trump Administration’s efforts to accelerate medical innovation and deliver breakthrough treatments.
FDA 23d ago ↗
FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
FDA today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis.
FDA 24d ago ↗
FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
Today, the U.S. Food and Drug Administration approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy patch for women with an intact uterus applied once a week.
FDA 24d ago ↗
FDA Issues Final Guidance on Prescription Drug Apps and Software
The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines.
FDA 25d ago ↗
FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
The U.S. Food and Drug Administration today granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) that may allow some patients with locally advanced rectal cancer to avoid common treatments that can have a lasting impact on their daily life.
FDA 30d ago ↗
FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development
The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases.
FDA 30d ago ↗
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FDA 39d ago ↗
FDA Seeks Public Input to Support Ibogaine Research
The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches.
FDA 42d ago ↗
FDA Approves First Heart Valve Designed to Grow with Children
The U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease.
FDA 44d ago ↗
FDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory Committees
The U.S. Food and Drug Administration today announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees— the independent bodies that inform some of the most consequential decisions in American public health.
FDA 44d ago ↗
FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
The U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals.
FDA 45d ago ↗
FDA Approves First Treatment for MCT8 Deficiency
The U.S. Food and Drug Administration today approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis (excess thyroid hormone levels in the blood that causes symptoms, such as rapid heart rate, increased blood pressure and adverse effects on metabolism) in patient
FDA 45d ago ↗
FDA intends to evaluate changes to the PMTA regulatory framework
FDA is carefully reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent judicial developments, including a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulatory framework.
FDA 50d ago ↗
Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions
A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.
FDA 53d ago ↗
FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing
The FDA today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they’re tried in humans.
FDA 56d ago ↗
FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A.
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