FDA approves an expanded indication for Abbott spinal cord stimulation (SCS) devices treating chronic back pain in those who have not had or are not ...
Five stakeholders comment on an FDA question-and-answer draft guidance on using electronic systems, records, and signatures in clinical investigations...
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.
