The Bespoke Gene Therapy Consortium, of which FDA is a member, chooses eight rare diseases for a clinical trial portfolio intended to speed the develo...
The Alliance for Pharmacy Compounding calls for changes to federal law to allow compounding pharmacies to help address temporary drug shortages under ...
A BMJ investigation questions how FDA approved Mercks antibiotic Recarbrio in 2019 since it did not appear to meet agency requirements for substantial...
FDAs Cellular, Tissue, and Gene Therapies Advisory Committee gives a split vote of 8 to 6 to recommend approval of a Sarepta BLA seeking accelerated a...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sanofis Cablivi (caplacizumab-yhdp).
FDA approves Allergan Aesthetics Skinvive by Juvderm and its use to improve skin smoothness of the cheeks in adults.
FDA clears a Waypoint Orthopedics 510(k) for the Waypoint GPS, a smart bone awl for use during pedicle screw pilot hole drilling.
FDA releases a final guidance entitled Reporting and Mitigating Animal Drug Shortages that covers voluntary submissions from sponsors so agency can he...
