FDA posts a REMS Platform Standards Initiative: Needs Assessment document that is intended to help standardize risk evaluation and mitigation strategi...
FDA Review posts the Federal Register notices for the week ending 7/14/2017.
FDA commissioner Scott Gottlieb touts agency efforts to reduce the countrys opioid epidemic.
Federal Register notice: FDA announces the availability of additional draft and revised draft product-specific guidances that provide product-specific...
Mallinckrodt files a citizen petition asking FDA to assure that follow-on drug products citing its Inomax (nitric oxide) 800 ppm for inhalation as the...
FDAs Oncologic Drugs Advisory Committee votes to support approval of an Amgen BLA for a biosimilar version of Roches Avastin (bevacizumab) and a Mylan...
FDA approves a Janssen Biotech BLA for Tremfya (guselkumab) for treating adults with moderate to severe plaque psoriasis who are candidates for system...
FDA approves an Amgen supplemental BLA for Blincyto (blinatumomab) to include overall survival data from the Phase 3 TOWER study, which also converts ...