Chester County News and Community Website
PHILADELPHIA, PA — The U.S. Food and Drug Administration recently granted Breakthrough Therapy Designation to plixorafenib, an investigational drug from FORE Biotherapeutics, for the treatment of adults with BRAF V600E-mutated …
FDA Grants Breakthrough Status to Fore Bio Brain Cancer Drug Read More
WASHINGTON, D.C. — Federal officials are restructuring offshore energy oversight by combining two key agencies into a single entity aimed at improving coordination and decision-making.
Interior Merges Offshore Agencies to Boost Oversight Efficiency Read More
CONSHOHOCKEN, PA — Hamilton Lane (Nasdaq: HLNE) recently received regulatory approval from the U.S. Securities and Exchange Commission for its Hamilton Lane Credit Income Fund, a new private credit vehicle …
Hamilton Lane Launches Credit Income Fund for Private Wealth Investors Read More
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. — 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