• STAT+: Advocates blast the FDA for not moving as fast on ALS as on Alzheimer's 

    12 days ago - By STAT

    WASHINGTON - The Food and Drug Administration fast-tracked Biogen's divisive Alzheimer's drug Aduhelm, but it's not going to do the same for amyotrophic lateral sclerosis anytime soon - and ALS advocates are outraged.
    The FDA approved Aduhelm on Monday under “accelerated approval,” a special pathway that lets the agency greenlight drugs based on so-called surrogate endpoints. That means drug makers can prove that tumors shrank or plaques in the brain disappeared, rather than demonstrating that the drug helps cure or treat a disease itself. The pathway had until now been used almost...
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