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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 ...
The American Journal of Managed Care4h
Linvoseltamab Offers Hope for Patients With Refractory Multiple Myeloma: Sundar Jagannath, MBBS
The FDA’s approval of linvoseltamab for adults with heavily pretreated relapsed/refractory multiple myeloma marks a significant advance, with Sundar Jagannath, MBBS, emphasizing its high response ...
FDA approves first cream for treating chronic hand eczema
The U.S. Food and Drug Administration (FDA) has signed off on the first-ever cream specifically approved for treating chronic ...
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 ...
Fierce Pharma7h
FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
MPR8h
FDA Approves Anzupgo for Chronic Hand Eczema
Delgocitinib is a JAK inhibitor that blocks the activation of the JAK-STAT pathway which has been shown to play a key role in the pathophysiology of chronic inflammatory skin diseases.
Urban Milwaukee8h
Vape Industry Sues Over Wisconsin Ban
You'll get access to an ad-free website with a faster photo browser, the chance to claim free tickets to a host of events ...
University of California9h
Do these two cancer drugs have what it takes to beat Alzheimer’s?
Li, Huang, and Sirota chose 2 cancer drugs out of the top 5 drug candidates for laboratory testing. They predicted one drug, ...
New medications coming soon: Here’s what’s been FDA approved in 2025 so far
GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...
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 ...