Monthly Prescribing Reference12h
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 Executive19h
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 ...
FDA approves Cobenfy for adults with schizophrenia
The U.S. Food and Drug Administration has approved Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride), a first ...