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 ...

Vinay Prasad is once again head of the FDA’s Center for Biologics Evaluation and Research, after Laura Loomer led a campaign ...

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

The Food and Drug Administration commissioner reveals what health officials are prioritizing in a forthcoming report on childhood chronic disease.

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

The Food and Drug Administration (FDA) is considering placing a black-box warning on antidepressant use in pregnancy, alarming some doctors who worry that a reignited debate about the drugs’ ...

President Trump’s FDA Begins Real-Time Reporting of Adverse Event Data Including for Product Quality Complaints for ...

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." ...

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

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