Add Yahoo as a preferred source to see more of our stories on Google. Moderna said the FDA's refusal was inconsistent with previous feedback from the agency. - Graham Hughes/Bloomberg/Getty Images The ...

Update: The FDA reversed its decision on Feb. 18 and agreed to consider Moderna's application. Read the latest here. Our earlier story is below. The Food and Drug Administration is refusing to ...

The FDA is refusing to consider Moderna's application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday. The news is the latest sign of the FDA's ...

RMAT designation requires preliminary clinical evidence addressing an unmet need in a serious disease and provides Fast Track/Breakthrough-like advantages, including frequent FDA interactions and ...

The U.S. Food and Drug Administration (FDA) announced Thursday it will relax federal regulations regulating when companies may label products as free of artificial coloring. The FDA said businesses ...

Vybrique is expected to be available in March 2026, with a direct to home delivery option being available to all states. The Food and Drug Administration (FDA) has approved Vybrique ™ (sildenafil) ...

There are plans for the FDA to next year begin testing some of the dairy ingredients in infant formula for botulism-causing spores, according to an agency official. The move comes in the wake of an ...

A central nervous system (CNS) tumor has prompted the FDA to place clinical holds on two Regenxbio gene therapies, including a candidate that is less than two weeks away from an approval decision.

OpenAI is releasing a new app called Prism today, and it hopes it does for science what coding agents like Claude Code and its own Codex platform have done for programming. Prism builds on Crixet, a ...

Please provide your email address to receive an email when new articles are posted on . Ianalumab has received the FDA’s breakthrough therapy designation for Sjögren’s disease. Novartis plans to ...

For the first time, Americans with depression will soon be able to use a prescription brain-stimulation device at home. The approval comes from the U.S. Food and Drug Administration and marks a major ...

Meghana Keshavan covers biotech and contributes to The Readout newsletter. Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.