FDA issues a guidance to help sponsors develop and conduct nonclinical studies during development of investigational enzyme replacement therapy produc...
FDA clears a Turner Imaging Systems 510(k) for its Smart-C Mini-C Arm Portable Fluoroscopy and X-Ray Imaging Device.
GlaxoSmithKline and Innoviva submits a supplemental NDA seeking an additional indication for once-daily use of Trelegy Ellipta for treating asthma in ...
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 ...