FDA approves 15 ANDAs representing the first generics of Takedas Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets, indicated for at...
Janssen Pharmaceutical files a supplemental BLA seeking an expanded approval for Rybrevant (amivantamab-vmjw) combination use with chemotherapy (carb...
Boston Scientific reports positive 12-month results from its pivotal ADVENT clinical trial of the FaraPulse Pulsed Field Ablation System, a nonthermal...
A Flag Pharma citizen petition asks FDA to revisit the therapeutic equivalence ratings of generic drug products that relied on bioequivalence studies ...
FDA clears a BioProtect 510(k) for its BioProtect Balloon Implant System, a next-generation spacer designed to provide protection to the rectum during...
AbbVie submits a supplemental BLA for Skyrizi (risankizumab) 1,200 mg intravenous (induction dose) and 180 mg and 360 mg subcutaneous (maintenance dos...
Novocure says its Phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 clinical trial of Tumor Treating Fields together with paclitaxel in patients with platinum-re...
Federal Register notice: FDA makes available a final guidance entitled Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the...
