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European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...
Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies ...
The recall has been given a Class II classification, indicating there is a significant level of risk posed to consumers in ...
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.
The review notes that the current legal limit for drinking water in the bloc is 1.5 milligrams of fluoride per liter, which ...
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
The mind-expanding drugs may help heal many mental health conditions. But studies haven’t actually proved that yet.
The FDA's 'Elsa' AI, intended to speed up drug approvals, is reportedly fabricating studies, part of a wider trend of ...
Nootropics are substances that enhance cognitive performance through various mechanisms, including cholinergic, glutamatergic, and dopaminergic pathways. They include prescription medications, natural ...