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AI in FDA Drug Approvals Sparks Controversy Over Fabricated Studies
In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...
FDA Sued Over Allegedly Defective Spinal Cord Stimulators
A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...
The FDA Is Using an AI to "Speed Up" Drug Approvals and Insiders Say It's Making Horrible Mistakes
Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...
FDA employees say the agency's Elsa generative AI hallucinates entire studies
Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated ...
Do fluoride supplements harm children? FDA panel discussion turns into heated debate
An FDA panel meeting featured a heated dialogue over whether fluoride supplements could pose health risks to children. Here's ...
Sarepta drops as report suggests FDA needs new trials for Elevidys
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
AstraZeneca Prepares Showdown With JNJ, Amgen With Phase 3 Win For Myasthenia Gravis Drug Candidate
AstraZeneca's gefurulimab showed clinical benefits and favorable safety in Phase 3 trial for adults with anti-AChR ...
100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar
Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
GSK's Blood Cancer Drug Review Extended As FDA Seeks More Data
FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.
Precision Medicine Online10h
Sarepta Halts Duchenne Gene Therapy Sales Amid FDA Scrutiny, Raising Concerns Over Financial Future
Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.
Prescription fluoride faces FDA scrutiny despite widespread support from providers and the public
The US Food and Drug Administration appears poised to continue with a plan to ban prescription fluoride supplements at a time ...
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FDA’s ‘Elsa’ AI For Faster Drug Approvals Under Fire for Hallucinating Studies, Highlighting Widespread Reliability Risks
The FDA's 'Elsa' AI, intended to speed up drug approvals, is reportedly fabricating studies, part of a wider trend of unreliable AI in high-stakes roles.