The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

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 ...

FDA approves Bravecto Quantum, the first injectable flea and tick treatment offering dogs up to 12 months of protection.

The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters related to medicines that were later approved, in a bid to improve transparency ...

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

A new U.N. AIDS agency report says the sudden withdrawal of U.S. funding has caused a “systemic shock” to the global effort ...

Ritz accidentally mislabeled peanut butter crackers as cheese crackers. After realizing the recent error, Mondelez ...

Weaver Nut Company, Inc. announced a recall for specific lots of its semi-sweet chocolate nonpareils on June 17 due to the undeclared presence of milk.

With the MLA alleging that he was served stale food, the State FDA collected samples from the canteen and sent them for ...

Certain packages of Ritz crackers have been recalled in the US over fears they could cause ‘life-threatening allergic ...

The FDA has granted 510(k) clearance to the TaviPilot AI software developed by Caranx Medical, according to company officials ...

Despite America's health policy turmoil, a number of ASX biotechs have announced big progress on their US expansion plans.