Company Name

Drug

Event

Outcome

Details

Sanofi
( SNYNF, SNY)

Nirsevimab (BLA)

Q3 2023
FDA decision on Nirsevimab for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months

FDA approves Nirsevimab for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months on July 17, 2023-

Drug Status

Eisai Co Ltd
(ESALY.PK)

LEQEMBI (sBLA)

07/06/2023
FDA decision in determining whether to convert accelerated approval of Alzheimer's drug LEQEMBI to a traditional approval

FDA granted traditional approval for LEQEMBI for the treatment of Alzheimer's disease on Jul.6, 2023-

Drug Status

Biogen Inc.
(BIIB)

LEQEMBI (sBLA)

07/06/2023
FDA decision in determining whether to convert accelerated approval of Alzheimer's drug LEQEMBI to a traditional approval

FDA granted traditional approval for LEQEMBI for the treatment of Alzheimer's disease on Jul.6, 2023-

Drug Status