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Roche announced data from a five-year follow-up of the pivotal phase III POLARIX study evaluating Polivy (polatuzumab vedotin) in combination with MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people [...]

Roche announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for [...]

AstraZeneca advances its ambition to redefine cancer care with new data across its industry-leading and diverse pipeline in haematology at the 66th American Society of Hematology (ASH) Annual Meeting and [...]

Roche announced that it will present more than 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held 7-10 December 2024 [...]

Roche announced positive topline results from the phase III REGENCY study of Gazyva/Gazyvaro (obinutuzumab) in people with active lupus nephritis. In the study, a higher proportion of people treated with [...]

BeiGene Ltd, a global oncology company, announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Brukinsa (zanubrutinib) for the treatment of adult patients with relapsed [...]

BeiGene, Ltd., a global biotechnology company, announced that the European Commission (EC) has granted marketing authorization for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with [...]

Roche announced it will be presenting more than 45 abstracts at the 65th American Society of Haematology (ASH) Annual Meeting and Exposition, spanning 10 haematology indications. New data reflect Roche's [...]

Roche announced that the European Commission (EC) has granted conditional marketing authorisation for Columvi (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma [...]

Roche announced that the US Food and Drug Administration (FDA) has approved Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) [...]

AbbVie announced new findings demonstrating sustained long-term safety and efficacy of Venclyxto/Venclexta (venetoclax)-based combination therapies in patients with previously untreated CLL with co-existing conditions, as well as R/R CLL. The [...]

Roche will be presenting new data on six approved and investigational medicines across ten cancer types at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held 2 -- [...]

Roche announced that the US Food and Drug Administration (FDA) has approved Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult [...]

Roche announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 in favour of Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) [...]

Roche announced that the European Commission approved the expansion of the Hemlibra (emicizumab) European Union (EU) marketing authorisation. The label will now include the routine prophylaxis of bleeding episodes in [...]

Roche announced that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) and granted priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific [...]

AstraZeneca's Calquence (acalabrutinib), a selective Bruton's tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with treatment-naȯve chronic lymphocytic leukaemia (CLL) (including small lymphocytic [...]

Chugai Pharmaceutical Co., Ltd. and Nippon Shinyaku Co., Ltd. announced that Chugai obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for an anti-cancer agent/humanized anti-CD20 monoclonal [...]

AstraZeneca will present 47 abstracts showcasing new data from across its haematology portfolio and clinical pipeline, demonstrating its commitment to redefining care for hard-to-treat blood diseases at the 64th American [...]

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion [...]

Roche announced that it is presenting new long-term follow-up results and subanalyses from clinical trials of its approved therapies, as well as data on investigational medicines from its broad blood [...]

AstraZeneca will showcase data demonstrating the company's commitment to redefine care in haematology at the European Haematology Association (EHA) Annual Meeting, 9 to 12 June 2022. A total of five [...]

AstraZeneca advances its ambition to redefine cancer care with new data to be presented across its diverse and industry-leading portfolio of cancer medicines at the American Society of Clinical Oncology [...]

TG Therapeutics, Inc., a biopharmaceutical company, announced that the company has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and Ukoniq [...]

Chugai Pharmaceutical Co., Ltd. and Nippon Shinyaku Co., Ltd. announced that Chugai filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW), for approval of an anti-cancer [...]

Roche announced European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular [...]

Roche announced that Venclexta (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients [...]

AbbVie announced new data from the phase 2 CAPTIVATE (PCYC-1142) study investigating Imbruvica (ibrutinib) in combination with Venclexta/Venclyxto (venetoclax), an all-oral, once-daily, chemotherapy-free, fixed-duration investigational combination, for patients with previously [...]

Final results from the head-to-head ELEVATE-RR phase III trial of AstraZeneca's Calquence (acalabrutinib) demonstrated non-inferior progression-free survival (PFS) and statistically significantly fewer events of atrial fibrillation versus ibrutinib in adults [...]

TG Therapeutics announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, the company's investigational glycoengineered anti-CD20 monoclonal antibody, in combination with [...]

Roche announced that the European Commission has approved Venclyxto (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia [...]

Chugai Pharmaceutical announced that it launched an anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion 30 mg and 140 mg [generic name: polatuzumab vedotin (genetical recombination)] for the treatment [...]

Chugai Pharmaceutical announced that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion 30mg and 140mg [...]

Roche announced longer-term data from the pivotal phase Ib/II GO29365 study, including data from a single-arm extension cohort of 106 additional patients, which show the benefit of Polivy (polatuzumab vedotin) [...]

TG Therapeutics announced that the company has initiated a rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) requesting approval of ublituximab, the [...]

AstraZeneca's Calquence (acalabrutinib), a next-generation selective Bruton's tyrosine kinase (BTK) inhibitor, has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), [...]

AstraZeneca's Calquence (acalabrutinib) has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of [...]

BeiGene Co, a commercial-stage biotechnology company, announced that its marketing authorization application (MAA) for Brukinsa (zanubrutinib) for the treatment of patients with WaldenstrȵmÇÖs macroglobulinemia (WM) who have received at least [...]

TG Therapeutics, a biopharmaceutical company, announced positive topline results from the global UNITY-CLL phase 3 trial evaluating the combination of umbralisib plus ublituximab (U2) compared to obinutuzumab plus chlorambucil in [...]

AbbVie, a research-based global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved the use of Imbruvica (ibrutinib) in combination with rituximab for the treatment of previously [...]

AbbVie, a research-based global biopharmaceutical company, announced that the European Commission (EC) has approved Venclyxto (venetoclax) in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia [...]

AbbVie, a research-based global biopharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for Venclyxto [...]

Roche announced that the European Commission has granted conditional marketing authorisation for Polivy (polatuzumab vedotin), in combination with bendamustine plus MabThera (rituximab) (BR), for the treatment of adult patients with [...]

AstraZeneca presented results from the interim analysis of the phase III ELEVATE TN trial, showing that Calquence (acalabrutinib) combined with obinutuzumab or as monotherapy significantly improved progression-free survival (PFS) compared [...]

Roche, announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Polivy (polatuzumab vedotin) in combination with bendamustine plus MabThera (rituximab) (BR) [...]

Roche announced data from the phase II NOBILITY study, investigating the safety and efficacy of Gazyva (obinutuzumab) for adults with proliferative lupus nephritis. The study met the primary endpoint with [...]

Roche, a global pioneer in pharmaceuticals and diagnostics company, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Gazyva (obinutuzumab) for adults with [...]

AstraZeneca, a global science-led biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult [...]

Roche announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of [...]