“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,” CEO Stephane Bancel said in the statemen ...

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 ...

The vaccine is expected to be commercially ready for the 2025-2026 COVID-19 season. The Food and Drug Administration (FDA) has approved Nuvaxovid ™ (COVID-19 Vaccine, Adjuvanted) for active ...

This FDA Recap highlights FDA approval of the first transcatheter aortic valve replacement system for treatment of asymptomatic aortic stenosis and the first leadless left ventricular endocardial ...

That change will be discussed at a meeting of FDA vaccine advisers later this week. The approval restricts the use of the vaccine, sold under the brand name Nuvaxovid, to individuals aged 65 and ...

But late Friday, the FDA granted the company full approval for its vaccine for use only in adults 65 and older – or those 12 to 64 who have at least one health problem that puts them at ...

Emrelis is the first FDA-approved antibody drug conjugate for advanced NSCLC with high c-Met protein overexpression, addressing a critical unmet need. The phase 2 LUMINOSITY study showed a 35% overall ...

The U.S. Food & Drug Administration (FDA) has announced the approval of three natural-source colors in food items. Galdieria extract blue, butterfly pea flower extract and calcium phosphate can ...

The FDA approved three natural food dyes this week amid its transition away from petroleum-based dyes in the food supply. The colors "will expand the palette of available colors from natural ...

RFK Jr. previously said he wants to phase out petroleum-based dyes. The U.S. Food and Drug Administration (FDA) approved on Friday additional color additives from natural sources in line with the ...