Doctors Blast Biogen Alzheimer Approval as ‘Regulatory Failure’ (Bloomberg):
Top researchers who advised the U.S. Food and Drug Administration on Biogen Inc.’s Alzheimer’s drug blasted the agency for approving it, calling the decision a “regulatory failure” that is “at odds with the evidence.” [Read more…] about Alzheimer’s & Dementia researchers challenge FDA’s approval of Aduhelm given lack of evidence for beta-amyloid as a marker
Good brief article at New Scientist, Maker of cognitive training game seeks FDA approval:
- “Imagine walking away from a doctor’s office with a prescription to play a video game. Brain Plasticity, the developer of a cognitive training game, has begun talks with the Food and Drug Administration (FDA) to market the game as a therapeutic drug.”
- “Brain Plasticity has been fine-tuning a game to help people with schizophrenia improve the deficits in attention and memory that are often associated with the disorder.”
