Chester County News and Community Website
SPRING HOUSE, PA — On Wednesday, the U.S. Food and Drug Administration (FDA) granted approval for IMAAVY™ (nipocalimab-aahu), Johnson & Johnson’s cutting-edge FcRn-blocking antibody treatment for generalized myasthenia gravis (gMG). …
FDA Approves Johnson & Johnson’s IMAAVY for Generalized Myasthenia Gravis Read More
NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has received FDA approval to move forward with its Virtue Trial, a pivotal clinical study designed to evaluate its next-generation …
Orchestra BioMed Secures FDA Clearance for Virtue Trial to Advance Coronary ISR Treatment Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) recently unveiled comprehensive plans to eliminate petroleum-based synthetic dyes from the …
ICYMI: FDA Declares War on Toxic Food Dyes in Bold Move to Protect Kids’ Health Read More NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) announced that its atrioventricular interval modulation (AVIM) therapy has received Breakthrough Device Designation (BDD) from the U.S. Food and Drug …
Orchestra BioMed Secures FDA Breakthrough Device Designation for AVIM Therapy Read More
WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ATI-052, a bispecific …
Aclaris Therapeutics Secures FDA Clearance for ATI-052 Clinical Trial Read More
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