The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

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 ...

French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...

The drug also had a favorable safety profile, indicating its potential as a game-changer for those with type 2 inflammation.

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity M ...

Earlier in 2019 Sanofi also paid Regeneron $462 million to exit from an immuno-oncology alliance formed in 2015, and in 2017 said they would end discovery research in new antibody drugs.

Sanofi and Regeneron could have approval for their new cholesterol-lowering drug alirocumab in the US before the end of July, giving it a real chance of beating rival Amgen to market. The Food and ...

Dupixent has been approved for CSU in Japan and the United Arab Emirates (UAE) and is also under regulatory review in the EU based on earlier study readouts. Outside of Japan and the UAE, the safety ...

Paris: Sanofi has announced that the European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic ...