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...
FDA posts a guidance on new enforcement deferments affecting enhanced drug distribution security requirements.
Inmar Supply Chain Solutions recalls FDA-regulated products (over-the-counter (OTC) human or animal drugs, OTC medical devices, dietary supplements, f...
CDER asks for comments on its proposal to withdraw Oncopeptides accelerated-approved multiple myeloma drug Pepaxto (melphalan flufenamide).
CDRH announces the qualification of a new tool through the agencys voluntary Medical Device Development Tools program: Accelerated Testing to Prove Lo...
FDA clears a Fresenius Medical Care 510(k) for VersiHD with GuideMe Software, a self-guided interface for the companys VersiHD chronic home hemodialys...
FDA grants Redx an orphan drug designation for zelasudil (RXC007) for treating idiopathic pulmonary fibrosis.
