FDA tells Insmed that it does not currently plan to hold an advisory committee meeting to discuss the companys NDA for brensocatib for patients with n...
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) plus Yervoy (ipilimumab) for a first-line treatment opt...
Drug compounding operations sue FDA in northern Texas federal court, seeking an order to reverse the agency decision last week to remove semaglutide (...
FDA rejects an Invivyd request to expand the existing emergency use authorization for pre-exposure prophylaxis of Covid-19 EUA for Pemgarda (pemivibar...
FDA approves a Mirum Pharmaceuticals NDA for Ctexli (chenodiol) for treating adults with cerebrotendinous xanthomatosis.
Pharmaceutical Research and Manufacturers of America says FDA should revise its recommendations for sponsors requesting meetings concerning cellular a...
In another blow to FDAs institutional knowledge, CBER deputy director Celia M. Witten leaves the agency amid a deepening staff exodus and plunging mor...
FDA says semaglutide injection product shortages (Novo Nordisks Wegovy and Ozempic) are resolved.
