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 (...
FDA says the Baxter Hillrom recall of WatchCare Incontinence Management Systems is Class 1.
Three Ropes & Gray attorneys describe some of the issues in a long-awaited FDA final guidance on clinical decision support software.
