Eisai and Biogen Overcome Filing Hitch, Initiate FDA Submission for Subcutaneous Leqembi

Eisai, Biogen, FDA submission, Leqembi, subcutaneous, Alzheimer’s disease, rolling submission, BLA, clinical trials, monoclonal antibody, amyloid beta, neurodegenerative disorder

FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.