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FDA advisors for COVID shots left in the dark over how they’ll be regulated
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 ...
STAT22hOpinion
The FDA is circumventing key roles and procedures for licensure and use of Covid vaccines
The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory ...
Capricor: High-Reward DMD Treatment Bet With Strong Data And Looming FDA Decision
Capricor's lead asset, deramiocel, targets DMD-related cardiomyopathy and faces key FDA milestones. Find out why CAPR stock ...
FDA approves Zynyz as first-line treatment for advanced anal cancer
The U.S. Food and Drug Administration has approved the humanized monoclonal antibody Zynyz (retifanlimab-dlwr) as the first ...
kffhealthnews2d
FDA, EPA Are Tasked With Speeding Up US Pharma Manufacturing Process
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 ...
FDA endorses 1st blood test to help diagnose Alzheimer’s disease
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.