FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
US FDA accepts for review the resubmission of sBLA for Dupixent to treat chronic spontaneous urticaria
US FDA accepts for review the resubmission of sBLA for Dupixent to treat chronic spontaneous urticaria: Paris Monday, November 18, 2024, 11:00 Hrs [IST] The US Food and Drug Admin
FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease
Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a decision expected by April 2025.
Sanofi, Regeneron Dupixent sBLA accepted for USFDA review for chronic spontaneous urticaria
Paris: Sanofi and Regeneron has announced that the US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA)
EMA approves Sanofi/Regeneron’s Dupixent for young EoE patients
The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and adults with EoE. Sanofi research and development head and e
FDA to Review Resubmitted Dupilumab sBLA for Chronic Spontaneous Urticaria
The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.
Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU)
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.
Regeneron, Sanofi Get New FDA Review of Dupixent for CSU
Regeneron Pharmaceuticals and Sanofi said the U.S. Food and Drug Administration has accepted their resubmitted application seeking expanded approval of the blockbuster anti-inflammatory drug Dupixent for the inflammatory skin condition chronic spontaneous urticaria,
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Sanofi: Diverse Drug Portfolio And Future Pipeline, 4% Dividend Yield Looks Attractive
A major news story from Sanofi this month is that "The European Medicines Agency has approved Dupixent (dupilumab) to ...
Sanofi, Regeneron's Dupixent SBLA Accepted For FDA Review To Treat Chronic Spontaneous Urticaria
French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...