The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...

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 ...

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 ...

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

We tend to think of COVID-19 as a respiratory illness. But, like many viruses, COVID can also affect your skin and cause ...

Commercial launch of neffy® (epinephrine nasal spray) underway in the United StatesSupplemental NDA for neffy®1mg dose granted priority review by FDA; PDUFA target date set for March 6, 2025Exclusive ...

Revenue: Total revenue was $2.1 million for the quarter ended September 30, 2024, comprised of $0.6 million in net product ...

ALK and ARS Pharmaceuticals sign a deal giving ALK global rights to Neffy nasal spray outside key regions, targeting peak ...

Medically reviewed by Jurairat J. Molina, MD Acute urticaria (hives) is a common skin condition that affects up to 20% of people at some point in their lives. It can transition into chronic urticaria ...