Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...
What Is Chronic Spontaneous Urticaria? Dermatologists Explain
Chronic spontaneous urticaria is an inflammatory skin disease that causes hives that last for at least six weeks. Derms ...
Monthly Prescribing Reference11h
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.
Medpage Today on MSN9d
Defining Treatment Success in Chronic Spontaneous Urticaria
With unfortunately no curative therapy for chronic spontaneous urticaria (CSU) available for now, the overall goal is to ...
MedPage Today4d
Chronic Inflammatory Dermatoses Weight Heavily on Quality of Life—Very Heavily
1 While second-generation H1-antihistamines are standard therapy for both acute and chronic urticaria, some patients need additional treatment to find relief. A new study investigates whether ...
Managed Healthcare Executive18h
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 ...
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.
PharmiWeb23h
Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric ...