U.S. FDA · Health
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- FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease7 d ago
The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recurre…
- FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients8 d ago
The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patien…
- FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing9 d ago
FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufactur…
- FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health13 d ago
The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to effi…
- FDA Approves First Single-Dose Generic Treatment for Influenza21 d ago
The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in pat…
- FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose23 d ago
The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency…
- FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes23 d ago
On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ages…
- FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children26 d ago
The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integ…
- FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats28 d ago
FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kitt…
- FDA Expands Sunscreen Options for the First Time in 20 Years30 d ago
Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen inno…
- FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients37 d ago
The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific and…
- FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs41 d ago
The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs.
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