FDA Drug Approvals

Company Name

Drug

Event

Outcome

Details

Biohaven Pharmaceutical Holding Co Ltd.
(BHVN)

Zavegepant nasal spray (NDA)

Q1 2023
FDA decision on Zavegepant nasal spray for the acute treatment of migraine in adults.

Pending-

Rival Drugs

MediWound Ltd.
(MDWD)

NexoBrid (Resubmitted BLA)

01/01/2023
FDA decision on NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns

FDA approved NexoBrid for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns on Dec.29, 2022-

Drug Status

Vericel Corporation
(VCEL)

NexoBrid (Resubmitted BLA)

01/01/2023
FDA decision on NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns

FDA approved NexoBrid for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns on Dec.29, 2022-