FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for …
1 day ago · The sBLA seeks approval for CSU in people aged 12 years and older whose disease is not adequately controlled with existing therapies like H1 antihistamines. The FDA’s decision …
Press Room - Sanofi US News
4 days ago · The sBLA adds results from Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C, the second …
FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for …
6 hours ago · 48.51. +0.54. +1.13%. Sanofi-Aventis S.A. ADR. Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their resubmitted supplemental …
Press Release: Dupixent sBLA accepted for FDA review for the …
3 days ago · The resubmitted sBLA is supported by data from the multi-study LIBERTY-CUPID phase 3 clinical program (Study A, Study B, and Study C) for Dupixent in CSU. The sBLA …
Sanofi, Regeneron's Dupixent SBLA Accepted For FDA Review To …
3 days ago · The sBLA for Dupixent (dupilumab) is to treat adults and pediatric patients aged 12 years and older with CSU whose disease is not adequately controlled with H1 antihistamine …
FDA Accepts sBLA Review for Dupilumab in Treatment of CSU in …
3 days ago · The resubmitted sBLA comes after supportive data from the LIBERTY-CUPID phase 3 clinical trial program (NCT04180488). The program consists of 3 phase 3 trials—study A, …
Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review
4 days ago · Nov. 15, 2024, 04:25 AM. Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License …
Press Room - Sanofi US News
Sep 12, 2023 · The U.S. Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) for ALTUVIIIO ® [Antihemophilic Factor (Recombinant), …
FDA Accepts sBLA of Dupilumab for the Treatment of Chronic …
4 days ago · Dupilumab's sBLA for treating CSU in patients 12+ is under FDA review, supported by phase 3 trial results. Adverse effects, including injection site reactions, were consistent with …
FDA to Review Resubmitted Dupilumab sBLA for Chronic …
3 days ago · The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines. The FDA has accepted for review the …