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WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) announced a series of actions last week aimed at strengthening consumer protections, advancing rare disease treatment development, and improving drug …
FDA Issues Series of Regulatory Actions Targeting Public Health, Transparency, and Drug Safety Read More
PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced that the U.S. Food and Drug Administration has agreed to the company’s rolling submission timeline for its Biologics License Application (BLA) for …
INOVIO Advances FDA Submission for INO-3107 in Rare Disease Treatment Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has begun publishing adverse event data from the FDA Adverse Event Reporting System (FAERS) on a daily basis, marking a …
FDA Begins Daily Publication of Adverse Event Data to Boost Drug Safety Oversight Read More
CONSHOHOCKEN, PA — ActiveProtective® has announced the commercial availability of its Tango® Belt, an FDA-authorized breakthrough medical device designed to protect older adults from fall-related hip fractures. The belt uses …
ActiveProtective Launches FDA-Authorized Tango Belt, an Airbag Device to Reduce Hip Fractures Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved Papzimeos (zopapogene imadenovec-drba), marking the first approved medical therapy for adults with recurrent respiratory papillomatosis (RRP), a rare …
FDA Approves First Immunotherapy for Rare Respiratory Papillomatosis Read More
MALVERN, PA — MAXONA Pharmaceuticals has taken a key step toward advancing its flagship pain therapy, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration …
MAXONA Pharmaceuticals Submits FDA Application for Non-Opioid Pain Treatment Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration has unveiled FDA PreCheck, a new initiative designed to strengthen the domestic pharmaceutical supply chain by making the process of building …
FDA Launches PreCheck Program to Boost Domestic Drug Manufacturing Read More
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