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.
FDA probes the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients treated with Amgens osteoporosis dr...
Federal Register notice: FDA is identifying two bulk drug substances that it has considered and proposes to include on its list of bulk drug substance...
The FDA Modeling and Simulation Working Group issues a report on how modeling and simulation are used within and across FDA Centers and opportunities ...
At FDAs request, GSK is withdrawing the accelerated approval for Blenrep (belantamab mafodotin-blmf) due to the therapys poor showing in progression-f...
