Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...

An FDA advisory panel concludes that the efficacy of brexpiprazole, when started concurrently with sertraline, has not been ...

Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...

The US Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ...

The Trump administration is inching closer to banning fluoride tablets and drops often prescribed to kids who don’t have ...

A new study by a Tulane University researcher casts doubt on a widely used shortcut in rectal cancer drug trials, raising ...

The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...

The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

The US Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from ...

FDA reviewers flag "discordant results" in a briefing document published ahead of Friday's advisory committee meeting for the ...