The US Food and Drug Administration has missed its latest deadline to propose banning formaldehyde and certain ...

Takeda and Protagonist Therapeutics have jointly submitted a new drug application (NDA) seeking approval from the US Food and ...

After Reviewing Historical Use and Modern Safety Evidence, Officially Confirms Kava is a Food Under Federal Law LOS ANGELES, ...

46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

Outlook Therapeutics said on Wednesday the U.S. health regulator has declined to approve its drug for a type of eye disease, ...

GSK Plc said it won US approval for a drug to treat severe asthma, boosting its prospects as a potential blockbuster.

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, the latest move by President Donald Trump’s ...

Vanda Pharmaceuticals said on Tuesday its drug for the prevention of motion-induced vomiting was approved by the U.S. health ...

Reading vitamin labels can sometimes be a mystifying experience. To help clarify, here are the various FDA vitamin labels and what they all mean.

AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or ...

In a series of high-impact moves, the FDA is reshaping how it approves and regulates drugs, including accelerating reviews, revising vaccine standards and simplifying biosimilar development.