Chester County News and Community Website
NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) announced a major expansion to the patient eligibility criteria for its ongoing BACKBEAT study, aimed at evaluating the effectiveness of its …
FDA Greenlights Broader Patient Access for AVIM Therapy Trial in Pacemaker Patients Read More
WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) in the treatment of …
AstraZeneca’s IMFINZI® Granted Priority Review for Early-Stage Gastric Cancer Treatment Read More
WASHINGTON, D.C. — In a sweeping regulatory move, the U.S. Food and Drug Administration (FDA) announced new safety labeling requirements for all prescription opioid pain medications, aiming to provide clearer …
FDA Orders Overhaul of Opioid Labels Amid New Evidence of Long-Term Risks Read More
WASHINGTON, D.C. — In a decisive step aimed at curbing the proliferation of potentially dangerous synthetic opioids, the U.S. Food and Drug Administration (FDA) announced recently that it is recommending …
FDA Moves to Restrict Potent Kratom Derivative 7-OH Amid Opioid Abuse Concerns Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has recommended lifting the voluntary clinical hold on Elevidys for ambulatory patients with Duchenne Muscular Dystrophy (DMD), following a thorough …
FDA Clears Path for Resumed Use of Elevidys Gene Therapy in Ambulatory DMD Patients Read More
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration, seeking approval to update the labeling for …
Johnson & Johnson Seeks FDA Nod for TREMFYA® Label Update Following Psoriatic Arthritis Trial Success Read More WASHINGTON, D.C. — Federal health regulators are investigating the death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics for Duchenne muscular dystrophy, a rare …
FDA Probes Death of Child Linked to Gene Therapy for Duchenne Muscular Dystrophy Read More
PHILADELPHIA, PA — GSK plc recently received approval from the U.S. Food and Drug Administration (FDA) for a prefilled syringe version of SHINGRIX, the company’s vaccine for shingles (herpes zoster). The …
FDA Approves Prefilled Syringe for GSK’s Shingles Vaccine, Streamlining Immunization Process Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration on Friday placed Sarepta Therapeutics’ gene therapy trials for limb girdle muscular dystrophy on clinical hold following the deaths of three patients …
FDA Shuts Down Sarepta Gene Therapy Trials After Three Deaths Linked to Liver Failure Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration announced a sweeping initiative on Wednesday to revoke or propose revocation of 52 food standards it deems obsolete or unnecessary. The move, …
FDA Launches Major Deregulation Drive, Targeting 52 Outdated Food Standards to Boost Innovation and Cut Red Tape Read More