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Betta Pharma Files for EMA Approval of ALK Inhibitor Ensartinib
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Betta Pharmaceuticals (SHE: 300558) announced the initiation of a market approval filing with the European Medicines Agency (EMA) for its anaplastic lymphoma kinase (ALK) inhibitor, ensartinib. The drug is under co-development with Betta affiliate Xcovery. The Chinese firm is seeking EMA approval for the drug’s use as a first-line treatment…
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FDA Approves Xcovery Holdings’ Ensartinib for Untreated ALK-Positive NSCLC Patients
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On December 18, 2024, the Food and Drug Administration (FDA) granted approval for Betta Pharmaceutical (SHE: 300558) and its controlling subsidiary Xcovery Holdings, Inc.’s ensartinib (Ensacove), a treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received…
