The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

A member of Columbia University's Board of Trustees is calling on the school to comply with the Trump administration's ...

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

Bread sold in a dozen states, including Ohio, has been recalled because the product may contain undeclared hazelnuts, ...

Prices are falling for the popular obesity treatments Wegovy and Zepbound, but steady access to the drugs remains challenging ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

Several food items sold in vending machines throughout Ohio, northern Kentucky, and eastern Indiana are being recalled due to an undeclared Sesame allergen, according to the U.S. Food and Drug ...

Hyaluronic acid fillers like Juvéderm can be dissolved using an enzyme called hyaluronidase. After allowing time for your ...

Store items in a cool, dry place away from direct sunlight. Place your food supply on high shelves to keep them far from any ...

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...