Cancer researchers from FDA and academic medical centers report recommendations from a panel of experts convened to find ways to improve drug developm...
FDA lifts its clinical hold on an Inhibikase trial of its IkT 148-009 in Parkinsons disease.
FDA issues a BsUFA 3 regulatory science research roadmap highlighting areas where pilot demonstration projects could improve science-based recommendat...
The FDA Oncology Center of Excellence and Aetion open a five-year collaboration to research oncology real-world evidence sources.
The manufacturer of the abortion pill mifepristone sues West Virginia over the states law that effectively bans using the drug for its FDA-approved in...
Merck terminates a Phase 3 trial of its Keytruda with other drugs as a treatment for some prostate cancers after an interim data review showed it miss...
An FDA advisory committee votes 14 to 1 to recommend that a Cidara Therapeutics NDA for rezafungin demonstrated a favorable benefit-risk profile in tr...
Emails released by FDA provide a glimpse of a frustrated senior FDA vaccine official arguing why her office could not compress its review activities a...
