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 ...

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

The following is a summary of “Integrative epidemiology and immuno-transcriptomics uncover a risk and potential mechanism for ...

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

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

I am proposing that all companies currently engaged in developing biosimilars join hands with their regulatory and scientific ...

The following is a summary of “Comparative safety of oral Janus kinase inhibitors versus dupilumab in patients with atopic ...

More than 1,000,000 patients are currently being treated with Dupixent globally.1 Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date ...

for Dupixent ® (dupilumab) 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 ...