Only 6% of trials for FDA-approved drugs match America's diversity. Analysis reveals how trial location and design choices ...

Thursday, the FDA addressed the shortfall with a label expansion for GSK’s Blujepa, which brings an oral option and a new ...

In a closely watched case, the U.S. solicitor general urged the Supreme Court to review a controversy over so-called skinny ...

Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

FDA may expedite approval timeline for Eli Lilly's weight-loss treatment, potentially moving decision date to late March from ...

The FDA is raising the bar for approval of CAR T-cell therapies in oncology. | The FDA is raising the bar for approval of CAR ...

GSK’s depemokimab, a long-acting biologic that’s key in the British pharma’s growth plan, has won an endorsement from ...

NEWS RELEASE: ten23 health QC lab to support commercial product testing for U.S. customer following FDA approvals Basel, ...

Marjorie Dannenfelser called for FDA Commissioner Marty Makary to be fired for allegedly delaying a mifepristone safety ...

"Considering the urgent global need for new gonorrhea treatments, the finding that a single-dose of oral zoliflodacin was efficacious at curing urogenital and rectal and pharyngeal gonorrhoea is ...