There's little point in pouring hundreds of millions of dollars into creating a biosimilar if PBMs will refuse to cover it.

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...

FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...

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

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

Several bulk boxes of Ritz cracker sandwich sleeves were recalled by their manufacturer and the FDA. Some peanut ...

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...

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

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

Understanding these trends will equip life sciences leaders with the knowledge to convert volatility into sustainable ...

An unusually large number of overdoses sent crews searching alleys and homes for victims. Officials have not said what type ...