FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.

The co-author of the book ‘Conspirituality’ explains how the far right is embedded in the world of wellness, obsessed with self-improvement but also with the dynamics of power and domination ...

Representative Lauren Boebert shared a photo of Clinton at the closed-door proceeding with a conservative influencer who posted it on social media.

Major equities indexes ended higher Monday after sharp gains to end last week, as tech stocks lifted the S&P 500 and Nasdaq, and the Dow Jones Industrial Average set fresh intraday and closing records ...

Proof-of-concept trial in a single patient shows that cells can survive transplantation without immunosuppression ...

After the FDA's surprise refusal to take up a review of Moderna's next-gen flu vaccine, the public disagreement between U.S. regulators and the mRNA specialist took a new turn Wednesday, with the U.S.

Correction: This story was updated to clarify a statement given by Department of Health and Human Services spokesperson Andrew Nixon. Moderna said on Tuesday that the Food and Drug Administration (FDA ...

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 ...

Moderna’s messenger RNA influenza vaccine succeeded in two pivotal clinical trials, but the Food and Drug Administration is refusing to even review the application seeking regulatory approval, telling ...

The Food and Drug Administration has declined to review Moderna’s application for the first mRNA-based flu vaccine, a decision that shocked the company and that comes as the agency plans to tighten ...

After crackdown threats from the FDA, Hims & Hers quickly pulled its copycat Wegovy pill, a cheaper compounded form of semaglutide. Compounded drugs are not FDA-approved and don’t go through the same ...

By Sriparna Roy March 2 (Reuters) - The Centers for Medicare & Medicaid Services intends to impose sanctions that would suspend enrollment in Elevance Health's Medicare Advantage prescription drug ...