The final Dec. 5 memo, according to FDA employees with knowledge of the situation, states that under an established World ...

The top vaccine regulator at the Food and Drug Administration (FDA) wants to impose vague but sweeping new standards on vaccine testing that, health experts say, would impede the development of new ...

The agency’s decision is based on claims that the Covid vaccine was linked to the deaths of 10 children.

George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...

The FDA’s top vaccine and gene therapy official, Vinay Prasad, MD, has resigned following an online campaign led by Laura Loomer, a right-wing influencer who targeted him over drug approval decisions, ...

Vinay Prasad, MD, former head of the FDA’s vaccine and gene therapy division who resigned under political pressure two weeks ago, is returning to the agency, The New York Times reported Aug. 9. Dr.

Meghana Keshavan covers biotech and contributes to The Readout newsletter. Today we talk about an advance in an experimental mRNA vaccine for HIV, dive deep on Vinay Prasad’s sudden FDA departure, and ...

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on ...

The FDA’s biologics chief cites Biden’s mistakes to justify slowing approvals.

An FDA official is getting his job back as the agency's top vaccine regulator, less than 2 weeks after he was pressured to step down at the urging of biotech executives, patient groups, and ...