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WASHINGTON, D.C. — A new weight-loss drug is now available months ahead of schedule after the U.S. Food and Drug Administration approved Foundayo (orforglipron) in just 50 days, marking one …
FDA Fast-Tracks New Weight-Loss Drug in Record Time Read More
PHILADELPHIA, PA — iECURE said the U.S. Food and Drug Administration has selected ECUR-506, the company’s investigational gene insertion therapy for neonatal-onset ornithine transcarbamylase deficiency, for the agency’s Chemistry, Manufacturing, …
FDA Selects iECURE Therapy for Manufacturing Readiness Pilot Program Read More
WASHINGTON, D.C. — Consumers will see clearer labeling on meat, poultry, and egg products under a new federal standard designed to ensure items labeled “Product of USA” are entirely sourced …
New ‘Product of USA’ Label Targets Consumer Confusion Read More
WASHINGTON, D.C. — Children with a life-threatening immune disorder now have a new treatment option following federal approval of the first gene therapy designed to correct the underlying cause of …
FDA Approves First Gene Therapy for Rare Childhood Immune Disorder Read More
SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) said the U.S. Food and Drug Administration has approved ICOTYDE (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and …
FDA Approves Johnson & Johnson Psoriasis Drug ICOTYDE Read More
WASHINGTON, D.C. — Children with a rare genetic disorder that affects the brain and body will have access to a newly approved treatment designed to slow disease progression, federal regulators …
FDA Approves First Treatment Targeting Hunter Syndrome Brain Effects Read More
WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) said the U.S. Food and Drug Administration has not identified bioequivalence deficiencies in its abbreviated new drug application for a preservative-free ketamine …
NRx Says FDA Finds No Bioequivalence Issues in Ketamine Filing Read More WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) said it has received written confirmation from the U.S. Food and Drug Administration supporting a path toward approval of its depression treatment …
NRx Says FDA Will Review NRX-100 Without New Trials Read More
PHILADELPHIA, PA — GSK plc (NYSE: GSK) said the U.S. Food and Drug Administration has expanded approval of its RSV vaccine AREXVY to include adults ages 18 to 49 who …
FDA Expands GSK RSV Vaccine Use to At-Risk Adults Ages 18–49 Read More
WASHINGTON, D.C. — A new higher-dose version of a widely used weight loss drug has been approved on an accelerated timeline, offering patients another treatment option as federal regulators test …
FDA Fast-Tracks Higher-Dose Weight Loss Drug Approval Read More