The FDA's push for lower-cost medicines looks good on paper, but the patent office under President Trump may be going in the ...

The U.S. Food and Drug Administration said on Wednesday that it has approved Bayer's drug for patients with a form of lung ...

In a new study, scientists discovered two FDA-approved cancer drugs that could also be effective at combatting one well-known ...

FDA aims to speed biosimilar approvals to increase competition, but experts warn drug prices may not drop quickly.

LOS ANGELES (KABC) -- The Food and Drug Administration's approval process is one of the most stringent in the world, but now some experts are questioning newer drugs that go through a quicker review.

The United States Food and Drug Administration (FDA) has removed "black box" warnings on many hormone treatments used to ...

WASHINGTON - The U.S. Food and Drug Administration plans to approve a new use for the generic drug leucovorin as a treatment for kids with autism. Trump, Health and Human Services Secretary Robert F.

The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster answers to follow-up questions after formal meetings with the agency.

The FDA is experiencing rising delays in drug approvals, raising concerns about operational strain within the agency, according to an RBC Capital Markets analysis. The Oct. 20 report, which was shared ...

The US Supreme Court on Monday rejected to review whether the FDA properly denied Vanda Pharmaceuticals Inc.'s application ...

Lower middle- and low-income countries are less likely to receive market authorization for drugs that were trialed within their state and approved by the FDA within 5 years of approval when compared ...

Private certification, insurer evaluation and peer-reviewed research step up.