Dupixent, Regeneron

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.
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.
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 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.
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 CSU, which causes sudden and debilitating hives and recurring itch.
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)
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
pharmaphorum1d
After FDA no, Regeneron gets yes from EU on odronextamab
Regeneron's CD20xCD3 bispecific antibody for non-Hodgin lymphoma (NHL) has been approved in Europe, five months after it was turned down by the FDA in the US. Ordspono (odronextamab) has been ...
Unlocking future medicines: The crucial role of clinical trials
Regeneron’s clinical trials are at the core of this mission. Regeneron is grateful to all clinical trial participants — ...
Managed Healthcare Executive2d
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 ...
pharmaphorum12d
FDA starts swift review of Regeneron’s CD20 bispecific
The FDA has started a priority review of Regeneron’s CD20xCD3 bispecific antibody odronextamab, seeking a broader label than other drugs in the class. The US regulator is reviewing odronextamab ...
Regeneron: Buying A Promising Pipeline At A Fair Price (Rating Upgrade)
Regeneron released a strong financial report for Q3 and was the 15th of 16 in the last four years. Read why I upgrade REGN ...