A federal judge in California ruled Monday that the Department of Health and Human Services (HHS) can share Medicaid data ...

A black-box warning is not a neutral informational update. It is the FDA’s most aggressive regulatory communication via product labeling, intended to alert clinicians and patients to risks so grave ...

Billions of prescriptions for generic drugs are filled in the U.S. annually. The FDA tests only a few dozen of them every ...

Visakhapatnam: Hundreds of scientists attending the 13th ‘international conference on preclinical insights from animal studies on drug discovery and t.

FDA is removing barriers to real-world evidence in device applications, allowing the use of de-identified patient data from ...

Amgen received approval from the Food and Drug Administration for its treatment for generalized myasthenia gravis, an autoimmune disorder. The pharmaceutical company said Thursday the drug Uplizna has ...

WASHINGTON – President Donald Trump and his top aides have justified lethal military strikes on suspected drug smuggling boats from Venezuela by accusing Venezuela and suspected criminal networks ...

The Biden administration withheld data from the public on the risks of myocarditis from the Covid vaccine, Food and Drug Administration Commissioner Marty Makary claimed Thursday — a bold accusation ...

Praxis Precision Medicine said it had completed its pre-new drug application meeting with the Food and Drug Administration for its essential tremor treatment. The company said Thursday it expects to ...

Former Food and Drug Administration commissioners said new vaccine standards threaten to put Americans’ health at risk and upend the agency’s scientific integrity. The 12 former FDA leaders criticized ...