Robust Pipeline To Pump Out Future Growth Regeneron's top blockbuster drug, Dupixent, was recently approved by the FDA for COPD treatment. However, this approval occurred when REGN was in a downward ...

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

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

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 ...

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 ...

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

Syndax’s Revuforj wins FDA go-ahead in leukemia Ahead of its Dec. 26 PDUFA date, Syndax Pharmaceuticals Inc. scored U.S. FDA approval of Revuforj (revumenib) as the first and only menin inhibitor for ...

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

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.