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 ...

The US Food and Drug Administration (FDA) has accepted a resubmission of the supplemental Biologics License Application for ...

Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)-4 and IL-13 pathways, is currently ...

Paris: Sanofi and Regeneron has announced that the US Food and Drug Administration (FDA) has accepted for review the ...

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 ...

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

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

to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target ...

to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target ...