FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria
The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for chronic spontaneous urticaria on April 18, 2025.
FierceBiotech21h
Intellia's CRISPR and Alnylam's RNAi data drops present contrasting visions for cardiomyopathy care
But the incumbents look set to fight to hold on to the market, with Alnylam Pharmaceuticals sharing early-phase data on its ...
PharmiWeb1d
Formycon receives positive CHMP opinion for FYB203…
Statement/Regulatory AdmissionFormycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama® 18.11.2024 / 06:30 ...
Pharmabiz1d
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 ...
The Pharma Letter1d
FDA accepts Dupixent sBLA resubmission for CSU
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License ...
Fintel on MSN2d
Wolfe Research Initiates Coverage of Regeneron Pharmaceuticals (REGN) with Outperform Recommendation
Fintel reports that on November 15, 2024, Wolfe Research initiated coverage of Regeneron Pharmaceuticals (NasdaqGS:REGN) with ...
Monthly Prescribing Reference3d
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.
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.
Managed Healthcare Executive3d
FDA Sets Date For Resubmitted Dupixent in Inflammatory Skin Disease
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...
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 ...
Regeneron, Sanofi Get New FDA Review of Dupixent for CSU
The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in ...