FDA publishes a final guidance to assist sponsors in submitting human factors information with medical device marketing applications to fit the FDA ri...
FDA publishes two final guidances on aspects of establishing bioequivalence.
FDA extends by three months its review timeline of a Beren Therapeutics NDA for adrabetadex for treating infantile-onset Niemann-Pick disease, Type C.
FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-nave, high-risk non-mus...
BrainStorm Cell Therapeutics names former FDA associate commissioner Peter Pitts to its board of directors.
Reps. Debbie Dingell and Rich McCormick say FDA should update its strategy for evaluating and identifying sepsis as a means to exclude inappropriate t...
FDA marks the 50th anniversary of the 1976 Medical Device Amendments by highlighting the laws lasting role in shaping the modern oversight of medical ...
FDA issues an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that could cause serious ...
