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From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.
European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...
Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.
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Que.com on MSNAI in FDA Drug Approvals Sparks Controversy Over Fabricated StudiesIn recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in ...
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.
Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.
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 ...
The US Food and Drug Administration (FDA) has instructed all GLP-1 drug-makers to update their warning labels to include the ...
In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...
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