Alzheimer’s & Dementia researchers challenge FDA’s approval of Aduhelm given lack of evidence for beta-amyloid as a marker

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.”

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Maker of cognitive training game seeks FDA approval

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.”…

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