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PHILADELPHIA, PA & COPENHAGEN, Denmark — Alveus Therapeutics said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for ALV-100, allowing the company to begin clinical …
FDA Clears Alveus Weight-Loss Drug, Launching U.S. Trial After First Dose Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration is moving on two fronts to strengthen consumer protection, launching a public review of gluten labeling practices while reporting sharp gains …
FDA Targets Gluten Labeling Gaps, Speeds Import Screening in Safety Push Read More
PHILADELPHIA, PA & SAN FRANCISCO, CA — Dispatch Bio said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for DISP-10, allowing the company to initiate …
FDA Clears Dispatch Bio’s Unusual Two-Step Immunotherapy for Solid Tumors Read More
WILMINGTON, DE — NRx Pharmaceuticals, Inc. said it has secured Fast Track designation from the U.S. Food and Drug Administration for NRX-100, a preservative-free ketamine formulation aimed at treating suicidal …
FDA Fast Track Puts Ketamine-Based Therapy in Spotlight for Suicide Care Read More
PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) laid out an ambitious 2026 roadmap centered on advancing rese-cel, its experimental CAR T cell therapy for autoimmune diseases, as the company …
Cabaletta Targets 2027 FDA Filing as Autoimmune CAR-T Push Accelerates Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration signaled a sweeping shift in how cutting-edge therapies reach patients this month, unveiling regulatory flexibility for cell and gene therapies, modernizing …
FDA Clears Faster Path for Gene Cures as Rare Disease Breakthrough Arrives Read More
PHILADELPHIA, PA — A rare-disease gene therapy developed in Philadelphia has cleared a major regulatory hurdle, positioning it on an accelerated path toward approval in the United States and the …
FDA Fast-Track Boost Lifts iECURE Gene Therapy Toward Hope for Newborns Read More
WASHINGTON, D.C. — The Food and Drug Administration has released a congressionally mandated review of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products, concluding that scientific evidence is too limited to …
FDA Finds Widespread PFAS in Cosmetics but Says Safety Data Falls Short Read More
PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) said the U.S. Food and Drug Administration has accepted its Biologics License Application for INO-3107, a potential non-surgical treatment for adults with recurrent …
FDA Sets 2026 Decision Clock for INOVIO’s Rare Disease Therapy Read More
LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) said it has resubmitted its biologics license application for MOLBREEVI to the U.S. Food and Drug Administration, a key regulatory step toward approval …
FDA Clock Restarts: Savara Refiles MOLBREEVI for Rare Lung Disease Read More