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

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

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

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

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...

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 ...

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

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

—This ongoing, prospective study examined quality of life in patients with 4 common CIDs: atopic dermatitis, psoriasis, hidradenitis suppurative, and chronic urticaria. Among the findings ...

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 ...

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 ...

The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.