The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for chronic spontaneous urticaria on April 18, 2025.

But the incumbents look set to fight to hold on to the market, with Alnylam Pharmaceuticals sharing early-phase data on its ...

Statement/Regulatory AdmissionFormycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama® 18.11.2024 / 06:30 ...

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

Fintel reports that on November 15, 2024, Wolfe Research initiated coverage of Regeneron Pharmaceuticals (NasdaqGS:REGN) with ...

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 (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...

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 ...

Fintel reports that on November 14, 2024, Citigroup initiated coverage of Regeneron Pharmaceuticals (NasdaqGS:REGN) with a ...