Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced a new policy directive to limit employees of FDA-regulated companies, such as pharmaceutical firms, from serving as official …
FDA Implements New Policy to Restrict Industry Ties on Advisory Committees Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced an ambitious effort to modernize drug testing by reducing reliance on animal models in favor of advanced, human-relevant …
FDA to Replace Animal Testing with Human-Relevant Methods for Drug Development Read More
WILMINGTON, DE — AstraZeneca‘s IMFINZI® (durvalumab) has gained FDA approval for use in adult patients with muscle-invasive bladder cancer (MIBC), making it the first perioperative immunotherapy available in the U.S. …
FDA Approves AstraZeneca’s IMFINZI® for Muscle-Invasive Bladder Cancer Read More
WASHINGTON, D.C. — Martin A. Makary, M.D., M.P.H., a distinguished surgeon, researcher, and health policy leader, was officially sworn in on April 1 as the 27th Commissioner of Food and …
Dr. Martin A. Makary Sworn in as 27th FDA Commissioner Read More
LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has announced the completion of its Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for MOLBREEVI, a potential treatment …
Savara Completes BLA Submission for MOLBREEVI to Treat aPAP Read More
PHILADELPHIA, PA — The U.S. Food and Drug Administration (FDA) has approved GSK’s Blujepa (gepotidacin), a groundbreaking oral antibiotic for treating uncomplicated urinary tract infections (uUTIs) in adult women and adolescents …
FDA Approves GSK’s Blujepa as First New Oral Antibiotic for UTIs in 30 Years Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced the approval of Qfitlia (fitusiran), a treatment designed to prevent or reduce the frequency of bleeding episodes in …
FDA Approves Qfitlia: A Breakthrough Treatment Revolutionizing Hemophilia Care Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has released a series of announcements covering a wide range of initiatives and regulatory updates, reflecting the agency’s ongoing commitment …
FDA Unveils Key Updates on Rare Disease Advances, Food Safety, and Medical Innovations Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has granted Visby Medical marketing authorization for its Women’s Sexual Health Test, a groundbreaking diagnostic tool that allows at-home testing …
Revolution in Healthcare: FDA Greenlights First At-Home Test for Three Major STIs Read More
BALA CYNWYD, PA — Larimar Therapeutics, Inc. (Nasdaq: LRMR) has announced significant progress in its nomlabofusp program for Friedreich’s Ataxia (FA), reporting key regulatory advancements, ongoing clinical developments, and a robust …
Larimar Therapeutics Advances Nomlabofusp Program Amid Regulatory Support Read More