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...
Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting consumer representative...
Federal Register notice: FDA publishes a list of PMAs and humanitarian device exemption applications that have been recently approved.
FDA seeks to eliminate the use of dogs in clinical research by animal drug developers.