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

Incyte (Nasdaq:INCY) today announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU). The decision was made following the ...

Jasper Therapeutics faces financial challenges but strong buy ratings. Read why JSPR stock is poised for growth amid risks ...

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 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 ...

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

Live webcasts of the presentations will be available on the Events & News – Events page of Jasper's Investor Relations website. An archived replay of each presentation will be available on Jasper's ...

Revenue: Total revenue was $2.1 million for the quarter ended September 30, 2024, comprised of $0.6 million in net product revenue for neffy sales, which reflects revenues from only one week following ...