2023 The Final Countdown, page-683

https://www.rttnews.com/corpinfo/fdacalendar.aspx


Subcutaneous Efgartigimod (BLA)
06/20/2023
FDA decision on SC efgartigimod for the treatment of generalized myasthenia gravis (gMG) in adults
Approved on June 20

SRP-9001 (BLA)
06/22/2023
FDA decision on SRP-9001 for the Treatment of Ambulant Individuals with Duchenne Muscular Dystrophy
Pending-

Aflibercept 8 mg (BLA)
06/27/2023
FDA decision on Aflibercept 8 mg for treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy.
Pending-

Valoctocogene Roxaparvovec (Resubmitted BLA)
06/30/2023
FDA decision on Valoctocogene Roxaparvovec for the treatment of severe hemophilia A in adult patients
Pending-

AVT04 (BLA)
2H 2023
FDA decision on AVT04, a proposed biosimilar to Stelara, which is prescribed to treat a variety of inflammatory conditions
Pending-

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

I/ONTAK (BLA)
07/28/2023
FDA decision on I/ONTAK for patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL)
Pending-