FDA approves Jazz Pharmaceuticals Vyexos to treat two high-risk types of acute myeloid leukemia.
FDA says Rugby Laboratories is recalling all lots of Diocto Liquid and Dicoto Syrup manufactured by PharmaTech due to possible contamination.
FDAs Arthritis Advisory Committee votes 12 to 1 against recommending approval of a Janssen Biotech BLA for Plivensia (sirukumab), citing safety concer...
A new email released under a lawsuit against FDA shows that former Office of New Drugs director John Jenkins delayed his planned retirement last year ...
The Senate passes an FDA user fee reauthorization bill to fund agency product reviews and related activities for the next five years.
Former CDC director Thomas Frieden says researchers need to be open to using new methods that may work better than randomized clinical trials in speci...
Attorney General Jeff Sessions announces formation of a pilot program to use data to help combat the nations opioid crisis.