HYMPAVZI (sBLA)
Q2 2026
FDA decision on HYMPAVZI to include the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) with hemophilia A or B without inhibitors
Pending-
AstraZeneca PLC
(
AZN, AZN.L, ZEG.DE, AZN.ST)
Baxdrostat (NDA)
Q2 2026
FDA decision on baxdrostat for treatment of adult patients with hard-to-control hypertension
Pending -
Nusinersen (sNDA)
04/03/2026
FDA decision on high-dose regimen of nusinersen for people living with spinal muscular atrophy (SMA)
FDA approved high-dose SPINRAZA (nusinersen) regimen For treatment of Spinal Muscular Atrophy on 30th March 2026.-