Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the supplemental Biologics License Application, or sBLA, for Dupixent to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria, or CSU, that is not adequately controlled with the current standard of care, H1 antihistamine treatment. The target action date for the FDA decision is October 22.
Published first on TheFly
See today’s best-performing stocks on TipRanks >>
Read More on REGN:
- Dupixent® (dupilumab) Application for Treatment of Chronic Spontaneous Urticaria (CSU) in Adults and Adolescents Aged 12 Years and Older Accepted for FDA Review
- Cantor Fitzgerald biotech analyst to hold analyst/industry conference call
- Kevzara® (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients with Polymyalgia Rheumatica
- Regeneron and Sanofi’s Kevzara approved by FDA for polymyalgia rheumatica
- Libtayo® (cemiplimab) in Combination with Chemotherapy Receives Positive CHMP Opinion for the Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)
