Nektar Therapeutics and Bristol Myers Squibb end their clinical development program for bempegaldesleukin in combination with Opdivo (nivolumab) for t...
FDA Review posts product approval summaries for the week ending 4/15/2022.
FDA clears a SonoScape 510(k) for its flagship video endoscopy system HD-550 for gastrointestinal diagnosis.
Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for Quick Turnaround Testing of Communication...
Federal Register notice: FDA makes available a final guidance entitled Bioavailability Studies Submitted in NDAs or INDs General Considerations.
Due to overall survival concerns, TG Therapeutics withdraws its accelerated approval of Ukoniq (umbralisib), a PI3K inhibitor for treating adults with...
FDA issues Hiers Enterprises (dba Northwest Compounding Pharmacy) a Form FDA-483 after inspecting the firm in 11/2021.