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FDA posts a draft guidance entitled Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products; Questions and Answers.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.
FDA approves a Samsung Bioepis BLA for Epysqli (eculizumab-aagh) as a biosimilar to Alexions Soliris (eculizumab), indicated for treating patients wit...
New studies by FDA drug promotion staff find that consumers conflated a drugs benefits and risks when they were exposed to both a disease awareness co...
