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.
Janssen says results of a head-to-head trial showed its Spravato had superior efficacy to Seroquel in patients with treatment-resistant depressive dis...
FDA approves an emergency use authorization for the Lucira Covid-19 and Flu Test.
Federal Register notice: FDA announces that a priority review voucher was redeemed 6/16 by AbbVie for a supplemental BLA for Skyrizi (risankizumab-rza...
FDA tells BioMarin Pharmaceutical that it no longer plans to hold an advisory committee meeting to review the companys resubmitted BLA for Roctavian (...
