By Puyaan Singh (Reuters) -KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had extended ...

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

The FDA plans to "unleash AI" on new drug evaluations in order to "radically increase efficiency in the review process." ...

Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after ...

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

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

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 ...

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

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.

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

U.S. drug companies are increasingly licensing experimental medicines invented by Chinese firms. Recent deals could be worth ...