FDA issues Aquestive Therapeutics a complete response letter on its NDA tadalafil oral film, a PDE5 inhibitor currently marketed (Eli Lillys Cialis) i...
FDA seeks input on how it can promote the development of digital technologies that would guide safe and effective prescription drug use to help patien...
FDA Review posts the Federal Register notices for the week ending 11/16/2018.
AstraZeneca and MedImmune say results from their Phase 3 MYSTIC trial involving Imfinzi (durvalumab) in lung cancer did not meet primary endpoints of ...
Senator Mike Enzi (R-WY) writes FDA commissioner Scott Gottlieb expressing concern over eventual senior staff turnover and asking for details of the a...
In less than two weeks after submitting a supplemental BLA, FDA approves a Seattle Genetics submission for Adcetris (brentuximab vedotin) for previous...
Pharmaceutical Manufacturing Research Services petitions FDA asking it to not approve any opioid product seeking an indication or any other labeling t...
Federal Register notice: FDA announces the availability of its annual report entitled Report on the Performance of Drug and Biologics Firms in Conduct...