Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved Journavx (suzetrigine) 50 milligram oral tablets, a groundbreaking non-opioid analgesic designed to treat moderate to severe acute pain …
FDA Approves First-in-Class Non-Opioid Pain Drug Journavx Read More
KING OF PRUSSIA, PA — SEED Therapeutics Inc. has announced that its molecular glue therapy, ST-01156, has been granted Rare Pediatric Disease and Orphan Drug designations by the U.S. Food and …
SEED Therapeutics Secures FDA Rare Pediatric and Orphan Drug Designations for ST-01156 Read More
MALVERN, PA — Biopharmaceutical company Ocugen, Inc. (NASDAQ: OCGN) has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for OCU500, a novel …
Ocugen Receives FDA Greenlight for Phase 1 Trial of Mucosal COVID-19 Vaccine Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced the authorization of 20 ZYN nicotine pouch products through its premarket tobacco product application (PMTA) pathway. This landmark …
FDA Grants First Marketing Authorizations for ZYN Nicotine Pouch Products Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has unveiled a proposal to introduce front-of-package (FOP) nutrition labels on most packaged foods, a move aimed at addressing the …
Unlock the Secret to Healthier Choices: Discover How New Food Labels Could Transform Your Diet Today! Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently released a draft guidance in collaboration with the Office for Human Research Protections, outlining recommendations for including tissue biopsies in …
FDA Issues Draft Guidance on Tissue Biopsies in Clinical Trials Read More
SPRING HOUSE, PA — The U.S. Food and Drug Administration (FDA) has granted Priority Review to Johnson & Johnson’s Biologics License Application (BLA) for nipocalimab, a treatment for generalized myasthenia …
Johnson & Johnson’s Nipocalimab Receives FDA Priority Review for Generalized Myasthenia Gravis Read More
RADNOR, PA — Mineralys Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 2 clinical trial …
Mineralys Therapeutics Receives FDA Clearance for Phase 2 Trial of Lorundrostat in Treating Sleep Apnea and Hypertension Read More
MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) has announced that the U.S. Food and Drug Administration (FDA) has accepted an updated protocol for the company’s pivotal Phase 3 Alzheimer’s (AD) …
FDA Accepts Revised Protocol for Annovis Bio’s Phase 3 Alzheimer’s Study Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced several critical developments spanning food safety, medical device oversight, and healthcare innovation. These updates reflect the agency’s ongoing …
Your Health at Stake: FDA Sounds the Alarm on Tainted Oysters, Shocking PFAS Packaging Risks, and Bold Medical Breakthroughs! Read More