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CStone announces positive registrational study of GAVRETO® (pralsetinib) in Chinese patients with RET-mutant medullary thyroid cancer
prnasia
June 28, 2021
CStone Pharmaceuticals, a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced positive results from China registrational study of the ...
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CStone announces positive GAVRETO® (pralsetinib) registrational study data for first-line treatment of advanced RET fusion-positive non-small cell lung cancer and plans to submit a new indication appl
prnasia
June 24, 2021
CStone Pharmaceuticals today announced data from the China registrational study of the global pivotal Phase 1/2 ARROW trial.
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CStone announces first prescriptions of precision therapy GAVRETO® (pralsetinib) issued across China for the treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell
prnasia
June 21, 2021
GAVRETO® (pralsetinib), a precision therapy discovered by CStone Pharmaceuticals' partner Blueprint Medicines, had the first batch of prescriptions issued at Guangdong Province People's Hospital and around 100 other hospitals across China.
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CStone Announces Acceptance of New Drug Application in Hong Kong, S.A.R., China for Avapritinib for the Treatment of Adults with Unresectable or Metastatic PDGFRA D842V Mutant Gastrointestinal Stromal Tumor
prnasia
May 12, 2021
CStone Pharmaceuticals, a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced the acceptance of the company's new drug application ...
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CStone Announces New Drug Approval of GAVRETO(R) (pralsetinib) as First Selective RET Inhibitor in China, Providing a New Therapy for a Subset of Non-Small Cell Lung Cancer Patients
prnasia
March 24, 2021
CStone Pharmaceuticals, a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies and precision medicines, today announces that the National Medical Products Administration (NMPA) of China has ...
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Blueprint Announces EMA Validation of Type II Variation Marketing Authorization Application for AYVAKYT
americanpharmaceuticalreview
March 09, 2021
Blueprint Medicines announced the European Medicines Agency (EMA) has validated the company's Type II variation marketing authorization application for AYVAKYT® (avapritinib) for the treatment of advanced systemic mastocytosis (SM).
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Catalent, Blueprint Enter GAVRETO Commercial Supply Pact
contractpharma
November 24, 2020
Following FDA approval and tech transfer, the Catalent team in Kansas City will support commercial supply of the non-small cell lung cancer drug.
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Blueprint Announces FDA Approval of GAVRETO for Metastatic Non-Small Cell Lung Cancer
americanpharmaceuticalreview
September 17, 2020
Blueprint Medicines announced the U.S. Food and Drug Administration (FDA) has approved GAVRETO™ (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer ...
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Blueprint Announces Top-line Data for Pralsetinib, Initiates Rolling NDA Submission
americanpharmaceuticalreview
January 14, 2020
Blueprint Medicines announced independent centrally reviewed top-line data for pralsetinib in patients with RET fusion-positive non-small cell lung cancer (NSCLC).
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Blueprint Medicines secures FDA approval for Ayvakit
pharmaceutical-technology
January 13, 2020
Blueprint Medicines has secured the US Food and Drug Administration (FDA) approval for Ayvakit (avapritinib) for treating unresectable or metastatic gastrointestinal stromal tumour among adults (GIST).