Chester County News and Community Website
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
WASHINGTON, D.C. — Federal regulators are moving to reduce the use of animal testing in drug development, issuing new guidance to help drugmakers adopt alternative methods that rely on human-based …
FDA Push to Replace Animal Testing Signals Major Shift Read More
WILMINGTON, DE — The U.S. Food and Drug Administration has accepted and granted Priority Review to a supplemental application for ENHERTU, a breast cancer treatment developed by AstraZeneca and Daiichi …
FDA Grants Priority Review to ENHERTU for Early Breast Cancer Use Read More
RADNOR, PA — Mineralys Therapeutics Inc. (Nasdaq: MLYS) reported its fourth-quarter and full-year 2025 financial results and said the U.S. Food and Drug Administration has accepted its new drug application …
Mineralys Reports 2025 Results, Advances Hypertension Drug Review Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched a new centralized system that will allow scientists, regulators, and the public to analyze safety reports for drugs, vaccines, …
FDA Launches Real-Time Safety Database for Drugs and Vaccines Read More