Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals Onpattro (patisiran).
FDA issues Byondis a complete response letter on its BLA for SYD985 ([Vic-] trastuzumab duocarmazine) for use in patients with HER2-positive unresecta...
The U.S. Supreme court decides to not hear a closely watched appeal of a lower courts ruling in a so-called skinny label case won by GlaxoSmithKline a...
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...
