FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the agency's Commissioner Marty Makary told CNBC.

The idea could help the administration achieve one of President Donald Trump’s main health-care goals: ensuring foreign countries aren’t getting a better deal on drugs.

The FDA typically does not make complete response letters public, citing confidentiality, putting the onus on the drug companies to share that information, which they often do selectively.

FDA raised safety concerns for Vyvgart Hytrulo in CIDP, while Argenx moves ARGX-119 into late-stage trials for rare neuromuscular disease.

The FDA has approved Gamifant as the first-ever treatment for macrophage activation syndrome in Still’s disease for adults and children who have an inadequate response or intolerance to ...

MRK's regulatory filing for once-daily HIV pill DOR/ISL gets FDA acceptance, with a decision expected by April 2026.

VYNE Therapeutics updates on VYN202, addressing FDA clinical hold; progress made in psoriasis treatment development.

According to the CDC, 1 in 5 American adults is living with obesity. In recent years, many have turned to weight loss drugs containing GLP-1, a hormone that slows digestion and helps with ...