The FDA will review the expansion of Anktiva plus BCG to patients with papillary-only bladder cancer, with a final decision expected by Jan.6, 2027. ・The acceptance reversed last year’s FDA refusal-to ...

Bayer said on Thursday that ​the U.S. Food and ‌Drug Administration had accepted its supplemental ​New Drug Application ​for ...

Moderna’s (MRNA) marketing application for its flu vaccine, mRNA-1010, will be reviewed by the FDA's independent experts next month, according to a federal notice posted on Thursday. The meeting of ...

The dispute between FDA and Boston-based Whoop turned up the heat in a simmering debate about how the agency ought to oversee ...

The Food and Drug Administration on Friday granted a quick review of three experimental psychedelic drugs meant to treat major depression and post-traumatic stress disorder.

The Food and Drug Administration in recent months has approved a small number of drugs quite quickly under a new expedited ...

Some psychedelic drugs, once considered fringe, are getting a step closer to possibly being approved for use as mental health treatments in the United States.

WASHINGTON (AP) — The Food and Drug Administration said Friday it will offer ultra-fast review to three psychedelic drugs being developed to treat mental health conditions, including depression, the ...

The FDA has linked Amgen’s vasculitis drug Tavneos to 76 postmarketing cases of drug-induced liver injury, including eight deaths, 54 hospitalizations and 74 serious outcomes. Seven patients developed ...

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.