Reuters reports that Johnson & Johnson will pay two Ohio counties $20.4 million to resolve opioid crisis claims.
The International Medical Device Regulators Forum publishes a draft medical device cybersecurity guidance.
The National Institutes of Health awards $29 million to fund five additional Research Evaluation and Commercialization Hubs to speed the translational...
FDA accepts for priority review a Merck NDA for Dificid (fidaxomicin) for oral suspension, and a supplemental NDA for a new indication for Dificid tab...
FDA approves a Puma Biotechnology labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast ...
Federal Register notice: FDA determines that 24 drug products were not withdrawn due to safety or effectiveness reasons.
Federal Register notice: FDA announces an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting to discuss immunological...
Federal Register notice: FDA makes available a draft guidance on Patient-Focused Drug Development: Methods To Identify What Is Important to Patients....