Spherix Global Insights says FDA approval of a new indication for Janssens Type 2 diabetes drug Invokana to slow the progression of diabetic kidney di...
FDA names Kaveeta Visisht to be associate commissioner for womens health.
FDA announces its Ethylene Oxide Sterilization Master File Pilot Program that is intended to allow companies that sterilize single-use medical devices...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug developers.
Federal Register notice: FDA seeks comments on a proposed information collection for Collection of Information for Participation in FDA Non-Employee F...
FDA issues a draft guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.
FDA clears a Renovia 510(k) for its next-generation Leva Pelvic Digital Therapeutic for strengthening pelvic floor muscles and treating stress urinary...
FDA issues Adamis Pharmaceuticals a complete response letter on its NDA for Adamis ZimHi (naloxone) high-dose injection for treating opioid overdose.