Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting ...

A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules ...

The FDA said it has begun publishing reports of adverse events concerning drugs on a daily basis, instead of quarterly, as it ...

The FDA now provides daily updates on adverse event reports for drugs and biologics via FAERS. Read more here.

The FDA is proposing an update to a decades-old orange juice rule that could give American citrus growers a boost — with ...

During his remarks in a Senate hearing in May, FDA Commissioner Marty Makary admitted to recklessly firing researchers at the Food and Drug Administration. Makary stated, "There have been a couple." ...

New FDA Rule Could Save Florida Orange Growers Millions Key Points Your morning glass of orange juice might taste exactly the ...

The FDA has accepted Stealth BioTherapeutics’ third new drug application for its ultra rare disease candidate, providing a ...

Sodium chloride 0.9% intravenous saline will be removed from the FDA Drug Shortage Database after supply has been restored.

U.S. Food and Drug Administration Commissioner Dr. Marty Makary, M.D., M.P.H., and U.S. Secretary of Agriculture Brooke L. Rollins this week announced plans to support American citrus growers ...

Currently, there are no FDA-approved drugs for NWS in the United States. The FDA can authorize the faster use of certain ...