Federal Register notice: CDRH announces a Software Precertification Pilot Program to evaluate a new approach for software products, including a precer...
FDA announces a 9/13 public workshop on Developing a Framework for Regulatory Use of Real-World Evidence.
FDA issues a safety alert after it received recent adverse event reports about Guardian Pharmacy Services compounded triamicinolone and moxifloxacin p...
Advanced Accelerator Applications resubmits an NDA for Lutathera (lutetium Lu 177 dotatate) for treating unresectable or metastatic, progressive, well...
AstraZeneca and Merck announce a collaboration to develop and commercialize AstraZenecas cancer drug Lynparza.
Aradigm files an NDA for Linhaliq (liposomal ciprofloxacin for inhalation) for treating non-cystic fibrosis bronchiectasis patients with chronic lung ...
A Tennessee federal court enters a permanent injunction stopping Crown Laboratories from distributing unapproved and misbranded drugs.
Federal Register notice: FDA classifies the assayed quality control material for clinical microbiology assays into Class II (special controls).