The FDA plans to “rapidly make available” rare disease drugs and make use of surrogate endpoints to get promising medicines ...

Moderna's (MRNA) new COVID vaccine approval targets a broader high-risk population. Check out why I see potential for a 25-40 ...

A new, highly transmissible COVID subvariant has been detected in California — heightening the risk of a summer wave as ...

Seven weeks into his job as FDA commissioner, Marty Makary, MD, MPH, held his own answering a barrage of sometimes ...

"With the COVID pandemic behind us, it is time to adopt a common-sense approach to COVID policy," a spokesperson for the FDA ...

The US Food and Drug Administration (FDA) has announced a significant revision to its COVID-19 vaccination policy, restricting access to seasonal booster shots for healthy Americans under the age of ...

In a significant shift of federal vaccine policy, the Food and Drug Administration announced Tuesday that access to updated COVID-19 vaccines this fall will be limited to older adults and individuals ...

The FDA will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...

WASHINGTON (AP) — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use ...

NEW ORLEANS — Last year, hundreds of people poured in to hear Peter Marks, the Food and Drug ... the gene therapy field is what stance Vinay Prasad, the fiery hematologist and frequent pharma ...

where everyone is still talking about Baby KJ and no one wants to talk about Vinay Prasad. Last year, hundreds of people poured in to see Peter Marks, the FDA’s head of biologics, speak at at ASGCT.