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 ...

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 ...

President Donald Trump's executive order limiting regulatory hurdles is intended to scale back the time it takes to get plants running. “We don’t want to be buying our pharmaceuticals from other ...

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 ...

U.S. SEC Commissioner Hester Peirce said the decade-long approval process for spot Bitcoin ETFs was “terribly mismanaged” at the time of the approval. Peirce urged those waiting for another round of ...

The AI tools will be deployed immediately and will expedite the review process by enabling FDA scientists and subject-matter experts to spend less time on “tedious” and “repetitive” tasks. FDA ...

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