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...
The American Pharmacists Association urges pharmacies to join them in calling for FDA to postpone the upcoming Drug Supply Chain Security Act (DSCSA) ...
Former FDA Oncologic Drugs Advisory Committee chairman Mikkael Sekeres looks at seven ways in which sponsor committee presentations can create problem...
