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Bimzelx (bimekizumab) two-year data at EHSF 2025 demonstrate sustained disease control in hidradenitis suppurativa – UCB

Written by | 11 May 2025

UCB announced long-term data from the BE HEARD trials for Bimzelx (bimekizumab) in moderate to severe hidradenitis suppurativa (HS). These two-year data, building on the established efficacy profile… read more.

FDA approves Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa – UCB

Written by | 15 Dec 2024

UCB,  announced that the FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx is the first and only approved… read more.

FDA approval for 320 mg single-injection device presentations of Bimzelx – UCB

Written by | 17 Oct 2024

UCB  announced that the FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx (bimekizumab-bkzx). These new device presentations add to… read more.

Late breaking data for Bimzelx (bimekizumab) from two year phase III studies in moderate to severe hidradentis suppurativa presented at EADV – UCB

Written by | 9 Oct 2024

UCB, announced the first presentation of two-year data from the Phase III studies, BE HEARD I and BE HEARD II, and their open-label extension, evaluating the efficacy and… read more.

European Commission approval for 320 mg device presentations of Bimzelx (bimekizumab) – UCB

Written by | 8 Aug 2024

UCB, a global biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorization for two 320 mg device presentations of Bimzelx (bimekizumab). The pre-filled syringe and… read more.

CHMP positive opinion for two 320 mg device presentations of Bimzelx (bimekizumab) – UCB

Written by | 5 Jun 2024

UCB, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting marketing authorization for… read more.

Health Canada approves Bimzelx (bimekizumab injection) for the treatment of adults with axial spondyloarthritis (axSpA) – UCB

Written by | 5 Apr 2024

UCB Canada Inc. is pleased to announce that Bimzelx (bimekizumab injection) has received authorization from Health Canada for two new indications. On February 23, 2024, BImzelx was approved… read more.

MHRA (UK) approves Bimzelx for patients with active psoriatic arthritis and adult patients with active axial spondyloarthritis – UCB

Written by | 10 Sep 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for bimekizumab (Bimzelx, UCB) for patients with active psoriatic arthritis and adult patients with active axial… read more.

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