[ Price : $8.95]
FDA tells Insmed that it does not currently plan to hold an advisory committee meeting to discuss the companys NDA for brensocatib...[ Price : $8.95]
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) plus Yervoy (ipilimumab) for a firs...[ Price : $8.95]
Drug compounding operations sue FDA in northern Texas federal court, seeking an order to reverse the agency decision last week to ...[ Price : $8.95]
FDA rejects an Invivyd request to expand the existing emergency use authorization for pre-exposure prophylaxis of Covid-19 EUA for...[ Price : $8.95]
FDA approves a Mirum Pharmaceuticals NDA for Ctexli (chenodiol) for treating adults with cerebrotendinous xanthomatosis.[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America says FDA should revise its recommendations for sponsors requesting meetings c...[ Price : $8.95]
In another blow to FDAs institutional knowledge, CBER deputy director Celia M. Witten leaves the agency amid a deepening staff exo...[ Price : $8.95]
FDA says semaglutide injection product shortages (Novo Nordisks Wegovy and Ozempic) are resolved.