Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the ...

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

The U.S. FDA faces challenges in meeting product review deadlines due to layoffs mandated by the Trump administration.

Critics worry that the user fee program creates a conflict of interest between the FDA and pharmaceutical companies.

DBV Technologies (DBVT) announced that in a written responses only to the company’s Type D IND meeting request, the FDA agreed with the ...

The FDA is the latest federal agency scrambling to meet the Trump administration’s return-to-office mandate. Monday was the ...

President Trump said his administration will release 80,000 files on the assassination of president Kennedy on Tuesday.

The FDA is recommending that flu vaccines for the 2025-26 season be trivalent, protecting against two strains of influenza A and one of influenza B.

(CNN) — The US Food and Drug Administration on Thursday issued recommendations for the composition of influenza shots for the upcoming respiratory virus season, but without input from its ...

Ampio Pharma's candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review.

Phase 3 AURORA trial of Descartes-08 in myasthenia gravis on track to commence in 1H25; Deep and durable responses maintained over 12 months in ...