Category Business

EU Widens Approval for Bristol Myers Squibb’s Reblozyl® for First-Line LR-MDS Anemia

Bristol Myers Squibb (NYSE: BMY) has disclosed that the European Commission (EC) has broadened the approval of Reblozyl® (luspatercept) to encompass the initial treatment of adult patients grappling with transfusion-dependent anemia linked to very low, low, and intermediate-risk myelodysplastic syndromes…

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US Accepts Biologics License Application for Datopotamab Deruxtecan in Advanced HR-Positive, HER2-Negative Breast Cancer Post-Prior Treatment

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been officially accepted in the United States. This application targets the treatment of adult patients grappling with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC…

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FDA Approves Astellas’ Supplemental New Drug Application for IZERVAY™ to Treat Geographic Atrophy

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, referred to as “Astellas”) has received notification from the U.S. Food and Drug Administration (FDA) regarding the acceptance of the company’s supplemental New Drug Application (sNDA). This acceptance pertains to…

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Bristol Myers Squibb Presents New Cardiovascular Findings at 2024 ACC Conference, Strengthening Evidence Base

Bristol Myers Squibb (NYSE: BMY) announced today the unveiling of data at the American College of Cardiology (ACC) Annual Scientific Session & Expo, scheduled for April 6-8, 2024, in Atlanta, Georgia. Roland Chen, MD, Senior Vice President and Head of…

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Awiqli®: European Authorities Recommend Approval for Weekly Basal Insulin Icodec in Diabetes Treatment

Novo Nordisk has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion, recommending the marketing authorization for Awiqli® (the branded name for once-weekly basal insulin icodec) for the treatment of…

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Legend Biotech Releases Debut Environmental, Social, and Governance (ESG) Report

Legend Biotech Corporation (NASDAQ: LEGN), a leading global figure in cell therapy, has unveiled its inaugural Environmental, Social & Governance (ESG) report. This comprehensive document provides an insight into Legend Biotech’s ESG initiatives, aligned with the Sustainable Accounting Standards Board…

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Viatris Announces Closure of Global Research and Development Collaboration with Idorsia: Official Statement

Viatris Inc. recently concluded agreements for a comprehensive global research and development collaboration with Idorsia Ltd (SIX: IDIA), a transaction that was finalized on March 15, 2024. For detailed information regarding this significant transaction, please consult Viatris’ Annual Report on…

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