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FDA to Review Confirmatory Data for Elahere in Platinum-Resistant Ovarian Cancer

The FDA has accepted for Priority Review the sBLA supporting the conversion to full approval of Elahere for platinum-resistant ovarian cancer.

Michael vasconcellesDrug administrationPriority reviewBiologics license applicationExecutive vice presidentPrescription drug user fee act

FDA Grants Priority Review to Mirvetuximab Soravtansine in FRα+ Platinum-Resistant Ovarian Cancer

The FDA has granted priority review to the supplemental biologics license application seeking the conversion of the accelerated approval of mirvetuximab soravtansine-gynx in patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who previously received 1 to 3 lines of systemic treatment to full approval.

Michael vasconcellesEuropean medicines agency acceptanceChina national medical products administrationP european medicines agencyImmunogen incPrescription drug user fee actNational medical productsMirvetuximab soravtansineOvarian cancerPlatinum resistant ovarian cancerFrα platinum resistant ovarian cancerPriority reviewPhase 3 soraya trialPhase 3 marisol trialAsco annual meetingAntibody drug conjugate

FDA to Review Confirmatory Data for Elahere in Platinum-Resistant Ovarian Cancer

The FDA has accepted for Priority Review the sBLA supporting the conversion to full approval of Elahere for platinum-resistant ovarian cancer.

Michael vasconcellesDrug administrationPriority reviewBiologics license applicationExecutive vice presidentPrescription drug user fee act

FDA Grants Priority Review of ImmunoGen s Supplemental Biologics License Application for ELAHERE in Platinum-Resistant Ovarian Cancer

WALTHAM - ImmunoGen, Inc. , a leader in the expanding field of antibody-drug conjugates for the treatment of cancer, today announced that the US Food and Drug Administration has filed the.

United statesMichael vasconcellesAnabel chanCourtney okonekEuropean medicines agencyCompany quarterly reports on formAmerican society of clinical oncologyImmunogen incNational medical products administration of chinaDrug administrationCompany annual report on formExchange commissionBiologics license applicationPriority reviewPrescription drug user fee actExecutive vice president

FDA Grants Priority Review of ImmunoGen s Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer

FDA Grants Priority Review of ImmunoGen s Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer
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United statesMichael vasconcellesImmunogen incExchange commission onNational medical products administration of chinaAmerican society of clinical oncologyDrug administrationCompany annual report on formCompany quarterly reports on formProduct serviceEuropean medicines agencyExchange commissionPriority reviewSupplemental biologics license applicationPlatinum resistant ovarianBiologics license application
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