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NICE positive for Brukinsa (zanubrutinib) to treat marginal zone lymphoma – BeiGene

Written by | 23 Sep 2024

NICE:(UK): Zanubrutinib is recommended, within its marketing authorisation, as an option for treating marginal zone lymphoma in adults who have had at least 1 anti?CD20-based treatment. It is… read more.

European Commission approval for tislelizumab as treatment for non-small cell lung cancer – BeiGene

Written by | 28 Apr 2024

BeiGene, Ltd. announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use…. read more.

FDA approval for Tevimbra for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy – BeiGene

Written by | 19 Mar 2024

BeiGene, Ltd. announced that the FDA has approved Tevimbra (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after… read more.

BLA application for Tevimbra (tislelizumab) for first-line gastric or gastroesophageal junction cancers accepted by FDA – BeiGene

Written by | 3 Mar 2024

BeiGene, Ltd. announced that the FDA has accepted a Biologics License Application (BLA) for Tevimbra (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients… read more.

European Commission approval for Brukinsa (zanubrutinib) for the treatment of relapsed or refractory follicular lymphoma – BeiGene

Written by | 28 Nov 2023

BeiGene, Ltd. announced that the European Commission (EC) has granted marketing authorization for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or… read more.

BeiGene announces positive regulatory updates in Europe and the U.S. after recently regaining global rights for Tevimbra (tislelizumab)

Written by | 7 Oct 2023

BeiGene, Ltd. announced that the European Commission (EC) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous… read more.

FDA approval sought for frontline Tevimbra (tislelizumab) in locally advanced or metastatic esophageal squamous cell carcinoma – BeiGene

Written by | 27 Sep 2023

The FDA has accepted for review a biologics license application (BLA) seeking the approval of tislelizumab (Tevimbra) for use in the frontline treatment of patients with unresectable, recurrent,… read more.

FDA grants Brukinsa accelerated approval in relapsed or refractory marginal zone lymphoma – BeiGene

Written by | 2 Feb 2022

BeiGene, Ltd. announced that Brukinsa (zanubrutinib) has received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL)… read more.

BeiGene receives positive CHMP opinion for Brukinsa for the treatment of adults with Waldenström’s macroglobulinemia

Written by | 2 Oct 2021

BeiGene has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of BRUKINSA (zanubrutinib)… read more.

Health Canada approves Brukinsa to treat Waldenstrom’s Macroglobulinemia – BeiGene

Written by | 4 Mar 2021

BeiGene, Ltd. a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that Brukinsa (zanubrutinib) has been approved by Health Canada for the treatment of… read more.

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