According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

U.S. Rep. Bob Latta, R-Bowing Green; Rep. Diana DeGette, D-Colorado; Rep. Dan Crenshaw, R-Texas; and Rep. Debbie Dingell, ...

MENOPAUSAL THERAPY IN FOCUS — The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet ...

Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...

The FDA has accepted for review the response to issues raised in the CRL for etripamil nasal spray (Cardamyst) for the treatment of PSVT.

Retail chatter around Klotho Neurosciences picked up late Thursday after the company said that the FDA had granted Orphan Drug Designation to its ALS gene therapy candidate, KLTO-202.

A Trump administration proposal to consider another form of drugs for Medicare price cuts is spurring legal and policy ...

The FDA has set a target action date of April 28, 2026, for the application under the Prescription Drug User Fee Act (PDUFA).

The long-awaited GOP proposal moves Harrisburg’s marijuana talks forward, but the issue still divides the Pa. Senate.

The FDA has accepted the New Drug Application for doravirine/islatravir for adults with virologically-suppressed HIV-1 infection.