Pfizer's COVID-19 vaccine for children under five may lose FDA authorization, leading to potential supply shortages. Modern ...

Dr. Vinay Prasad is resuming leadership of the FDA center that regulates vaccines and biotech therapies, a spokesperson for ...

Shares of several biotech firms fell in premarket trading Monday after reports that ousted U.S. Food and Drug Administration ...

Alnylam Pharma raised its revenue outlook as its heart drug sees quick uptake.

Reports second quarter revenues of $0.1 billion, GAAP net loss of $(0.8) billion and GAAP EPS of $(2.13) Updates 2025 ...

Moderna announced layoffs affecting 10% of its workforce amid government and competitive challenges to its vaccine business ...

Business FDA approves Moderna’s new lower-dose COVID-19 vaccine FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015.

You could be forgiven if you believed that the FDA granted full approval to Moderna's COVID-19 vaccines for children yesterday. Indeed, that's how many major media outlets portrayed things.

An FDA official is getting his job back as the agency's top vaccine regulator, less than two weeks after he was pressured to ...

The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company’s existing shot, but a second option.

The FDA’s approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna’s existing vaccine. It found the new vaccine was safe and was at ...