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.

The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...

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

The U.S. Food and Drug Administration has approved Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride), a first ...

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 ...

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

2 Top Growth Stocks to Buy on the Dip was originally published by The Motley Fool ...

Researchers are exploring how small airway abnormalities in younger smokers could help identify who is at risk of developing COPD and establish how the chronic lung disease progresses.

After years of limited advancements in chronic obstructive pulmonary disease (COPD) treatment ... or occupational dust. Also ...