FDA denies a petition seeking Risk Evaluation and Mitigation Strategiesfor Behrings simultaneously approved Hemophilia B gene therapy Hemgenix (etrana...
CDRH qualifies the CHemical RISk calculator Color Additives under its Medical Device Development Tools program.
The journal Science says safety questions are being raised about Eisai and Biogens lecanemab (BAN2401), an investigational anti-amyloid beta protofibr...
FDA sends Spectrum Pharmaceuticals a complete response letter rejecting the companys poziotinib and its use in treating certain patients with previous...
Federal Register notice: FDA announces a 1/9 Dermatologic and Ophthalmic Drugs Advisory Committee meeting to discuss a Regeneron Pharmaceuticals suppl...
FDA alerts healthcare professionals about potential compatibility issues with prefilled glass syringes and certain Luer-activated valve connectors.
Federal Register notice: CDER proposes to withdraw the approval of an NDA 006499 for Bufferin (aspirin) tablets because it has not received required a...
FDA clears a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage (ICH) triage and notification device.
