Chester County News and Community Website
PHILADELPHIA, PA — GSK plc (NYSE: GSK) secured U.S. Food and Drug Administration approval for Hibsago, a hepatitis B treatment that achieved functional cure in 19% of eligible clinical trial …
FDA Approves GSK’s Hibsago for Chronic Hepatitis B Read More PHILADELPHIA, PA — The U.S. Food and Drug Administration has granted accelerated approval to GSK’s Jemperli as a standalone treatment for certain patients with locally advanced rectal cancer, creating an …
FDA Approves GSK’s Jemperli for Certain Rectal Cancer Patients Read More
WARMINSTER, PA — Arbutus Biopharma Corporation (Nasdaq: ABUS) has received clearance from the U.S. Food and Drug Administration to resume clinical development of its experimental hepatitis B treatment AB-101 in …
Arbutus Wins FDA Clearance to Resume Hepatitis B Drug Trials Read More
WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) has completed commercial-scale manufacturing validation for its preservative-free injectable ketamine, positioning the company to begin supplying U.S. hospitals and clinics if the …
NRx Clears Manufacturing Hurdle for Ketamine FDA Review Read More
WEST CHESTER, PA — Centinel Spine has secured U.S. Food and Drug Administration approval to use its prodisc C Nova artificial cervical disc at two levels of the spine, expanding …
West Chester Medical Firm Gains Ground With FDA Decision Read More WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) is approaching a November 10 federal regulatory decision on its preservative-free ketamine product after the Food and Drug Administration requested only minor …
NRx Nears FDA Decision on U.S.-Made Ketamine Product Read More
CLAYMONT, DE — MRI2CT Inc. has received U.S. Food and Drug Administration 510(k) clearance for an artificial intelligence imaging platform that generates three-dimensional bone images of the lower spine from …
MRI2CT Secures FDA Clearance for AI Spine Imaging Platform Read More
MALVERN, PA — TELA Bio Inc. (NASDAQ: TELA) has received U.S. Food and Drug Administration clearance for a fully resorbable surgical mesh developed and manufactured at its Malvern facility, expanding …
TELA Bio Wins FDA Clearance for Resorbable Surgical Mesh Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration is seeking public input on safety requirements and clinical trial designs for ibogaine, a psychedelic compound being investigated for opioid use …
FDA Seeks Input on Ibogaine Trials Amid Safety Concerns Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration approved the Autus Size-Adjustable Valve for children with congenital pulmonary valve disease, creating the first U.S. heart valve designed to expand …
FDA Clears Expandable Heart Valve for Children Read More