The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...

The U.S. Food and Drug Administration has declined to approve Corcept Therapeutics' drug for the treatment of a rare hormonal ...

Dec 2 (Reuters) - The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical toxicity studies for certain monoclonal antibodies. The ...

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo WASHINGTON (Reuters) -The U.S.

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 ...

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo (Reuters) -The U.S.‌ Food and ...

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.

President Trump’s Food and Drug Administration is cracking down on the “endless” barrage of pharmaceutical advertisements Americans are hit with on a daily basis, FDA Commissioner Marty Makary said on ...

As the U.S. works several levers to lower drug pricing, such as Medicare negotiating costs with drugmakers and President Donald Trump launching TrumpRx, a report from the IQVIA Institute quantified ...

U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would face fresh safety scrutiny following ...