Federal Register notice: FDA develops a list of drug products and categories of drug products that are difficult to compound.
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 ...
Intellipharmaceutics says it will try to resolve concerns raised by FDA advisors about its Rexista abuse-deterrent opioid.