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Verastem Oncology Announces the Initiation of a Rolling Submission of NDA to FDA Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

Verastem Oncology Announces the Initiation of a Rolling Submission of NDA to FDA Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer
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South koreaUnited kingdomDan patersonEuropean network of gynaecological oncological trialChugai pharmaceutical co ltdCompany annual report on formExchange commissionRaf and mek programGenfleet therapeutics shanghai incSecura bio incDrug administrationFoundation incVerastem oncologyNew drug applicationBreakthrough therapy designationOrphan drug designation

FDA Grants Breakthrough Therapy Designation to NVL-655 for Pretreated ALK+ NSCLC

FDA Grants Breakthrough Therapy Designation to NVL-655 for Pretreated ALK+ NSCLC
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FDA Accepts BLA for Subcutaneous Nivolumab in Advanced or Metastatic Solid Tumors

The FDA has accepted a biologics license application for subcutaneous nivolumab for adult patients eligible for approved solid tumor nivolumab indications.

United statesGina fusaroDrug administrationBristol myers squibbEuropean unionPrescription drug user fee actBlinded independent centralBristol myersSubcutaneous nivolumabSubcutaneous nivolumab in advanced or metastatic solid tumorsFda blaCheckmate 67t study nct04810078

SpringWorks Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J P Morgan Healthcare Conference

STAMFORD, Conn., Jan. 08, 2024 SpringWorks Therapeutics, Inc. , a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, will present today at the 42nd Annual.

United statesSamantha hilson sandlerSaqib islamEuropean hematology associationAmgen incBeigene ltdExchange commissionDrug administrationEuropean medicines agencySpringworks therapeutics incAmerican association for cancer researchWorks therapeuticsHealthcare conferenceUnited states foodNew england journalBlinded independent central

Verastem Oncology Announces Initiation of a Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

Verastem Oncology Announces Initiation of a Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer
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United kingdomUnited statesCity ofSusana banerjeeRyan porterDan patersonRachel grishamElisa buffingtonResearch lead for the gynaecology unitSecura bio incFoundation incEuropean society of gynaecological oncologyCorporate communicationsNational cancer instituteInstitute of cancer researchEuropean network for gynaecological oncological trial