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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

US FDA accepts sBLA for GSK s Jemperli for broader endometrial cancer use - Pharmaceutical Business review

GSK has received the US Food and Drug Administration’s (FDA) acceptance for its supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) along with standard-of-care chemotherapy (carboplatin and paclitaxel).

European network of gynaecological oncological trialDrug administrationSociety of gynecologic oncologyBiologics license applicationPriority reviewPrescription drug user fee actGynecologic oncologyAnnual meetingEuropean networkGynaecological oncological trial

GSK : Jemperli (dostarlimab) plus Zejula (niraparib) combination significantly improved progression-free survival in primary advanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial - Form 6-K -December 18, 2023 at 06:38 am EST

a1192x UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER.

United kingdom generalUnited kingdomTreasure islandUnited statesCity ofJames dodwellTim foleyCamilla campbellJeff mclaughlinMick readeyDan smithHesham abdullahJosh williamsLyndsay meyerSteph mountifieldKathleen quinn

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

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

Verastem Oncology (VSTM) Announces Initiation of a Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer
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City ofUnited kingdomDan patersonRachel grishamSusana banerjeeDrug administrationInstitute of cancer researchFoundation incCompany phaseResearch lead for the gynaecology unitEuropean network of gynaecological oncological trialTeam leader in women cancersVerastem oncologyChief executive officerBreakthrough therapy designationAccelerated approval