ADDF’s Fillit On FDA’s Tough Aducanumab Decision, Advances In Alzheimer’s
New Blood Test Should Aid Drug Trials, Symptomatic Treatments Advancing
The pending US FDA decision on Biogen’s drug overshadows progress in Alzheimer’s diagnosis, symptomatic treatments and the need to keep studying anti-tau therapies after Roche’s setback.
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Biogen's stock soared 44% after the US FDA released briefing documents for a high-profile advisory committee meeting to review aducanumab for Alzheimer's disease.
Axsome is set to file for approval in the second half of 2020.
After initially being rejected last year by the US FDA, Lilly's non-therapeutic radiopharmaceutical Amyvid (florbetapir F 18 injection) gained regulators blessing to enter the US market as a brain imaging agent of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.