The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' drug for a type of hereditary swelling ...

The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a ...

Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS ...

The U.S. Food and Drug Administration on Thursday approved UroGen Pharma's drug to treat a type of bladder cancer, providing ...

The global watchdog of doping in sports says it will urge public authorities to shut down the drug-fueled Enhanced Games ...

The US Food and Drug Administration (US FDA) has officially approved Nutriasia’s petition to remove Mang Tomas All Purpose Sauce, Jufran Banana Sauce, and UFC Banana Sauce (both Regular and Hot ...

According to a regulatory filing by the company, the US FDA conducted a Good Manufacturing Practices (GMP) inspection at the ...

(Reuters) -The U.S. Food and Drug Administration has placed a clinical hold on Gilead Sciences' trials testing a combination ...

The U.S. Food and Drug Administration has rolled out a new AI assistant, Elsa, that it says will increase efficiency at its ...

A former FBI official says the Department of Justice's decision to hit two Sinaloa cartel members with terrorism-related ...

Two people were charged in the investigation in the south suburbs, and authorities recovered more than 15 pounds of fentanyl and 25 guns, according to the U.S. Drug Enforcement Administration.

CNBC-TV18 had first reported the US FDA's surprise visit on June 3. The regulator has now issued a Form 483 with eight observations after a GMP inspection at Sun Pharma’s Halol unit.