The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising questions about whether the agency's new leadership may be rowing back from ...

Gland Pharma’s Pashamylaram facility has received GMP compliance certification from the Danish Medicines Agency for ...

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

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

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

Dr. Marty Makary, FDA commissioner, joins 'Squawk Box' to discuss what hindsight tells science about the best route to take post-Covid, changes to the Vaccine Advisory Committee and much more.

Dr. Marty Makary, FDA commissioner, joins 'Squawk Box' to discuss what hindsight tells science about the best route to take post-Covid, changes to the Vaccine Advisory Committee and much more.

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

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

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

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

INDIANA- FDA advises consumers not to inhale nitrous oxide products from any size canisters, tanks, or chargers. These ...