At the outset of the meeting, the FDA's new top vaccine regulator, Vinay Prasad, said he and FDA leaders wanted to "give people a little more time to digest the policy." He said that the FDA is still ...

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory ...

Capricor's lead asset, deramiocel, targets DMD-related cardiomyopathy and faces key FDA milestones. Find out why CAPR stock ...

The U.S. Food and Drug Administration has approved the humanized monoclonal antibody Zynyz (retifanlimab-dlwr) as the first ...

Neurologist Dr. Leah Croll reports on the first ever blood test approved by the Food and Drug Administration, giving the test a “breakthrough device” designation to fast-track the approval process.

U.S. health regulators announced plans Tuesday to phase out fluoride-containing supplements sometimes used to strengthen ...

Advancing commercial readiness efforts with a planned Q1 2026 launch of Anaphylm, subject to FDA approval "In the first quarter of 2025, we achieved a major milestone for Aquestive with the submission ...

The Food and Drug Administration said it is granting petitions to allow galdieria extract blue, a blue color derived from ...

Ahead of its anticipated FDA approval, Teal Health raised $10 million in its latest funding round in January to help ramp up production for the launch of the Teal Wand. The investment was led by ...