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

US regulators laid out new guidelines for approving custom-made treatments for individual patients, a move that could bring ...

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

FDA approves 1st biosimilar to Perjeta, Poherdy, for HER2-positive breast cancer treatment, enabling pharmacy-level substitution under state law.

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 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 Food and Drug Administration has named a longtime regulator of cancer medications to lead the agency’s drug center.

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.

Richard Pazdur, a longtime Food and Drug Administration employee, will lead its center that oversees over-the-counter medicines and the majority of prescription drugs.

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

They say the FDA should have convened its independent advisers to publicly consider any revisions. Current medical guidelines generally recommend the drugs for a limited duration in younger women ...

Dr. George Tidmarsh had been placed on leave Friday after Health and Human Services officials were notified of the issues, a ...