Merck reports positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab in treating respiratory syncytial virus...
Experts from FDA and two other groups publish considerations for the use of overall survival as an endpoint in cancer clinical trials.
FDA accepts a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL, indicated for treating diabetic macular edema and diabetic ret...
FDA clears a Think Surgical 510(k) for its Tmini Miniature Robotic System with Tmini 1.1. software for total knee arthroplasty procedures.
FDA plans to ask an advisory committee 7/25 whether a new trial should be conducted before approving an AstraZeneca supplemental BLA for Imfinzi (durv...
FDA posts a draft guidance entitled Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products; Questions and Answers. ...
Federal Register notice: FDA corrects a 7/2 notice that announced the determination of the regulatory review period for Sanofis Xenpozyme (olipudase a...
Johnson & Johnson seeks approval of Spravatos (esketamine) approval as monotherapy for adults living with treatment-resistant depression.
