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FDA Accepts BLA for Afami-Cel for Priority Review as Treatment of Advanced Synovial Sarcoma

Afami-cel had engineered t-cell receptor T-cells target MAGE-A4+ tumors, which are highly expressed in synovial sarcoma with HLA-A 02.

Dennis williamsConnective tissue oncology societyEastern cooperative oncology groupStage development at adaptimmune therapeuticsAdaptimmune therapeuticsPrescription drug user fee actLate stage developmentTissue oncology societySubjects with advanced synovial sarcomaRound cellCompletion date

FDA Grants Priority Review to Afami-Cel BLA in Advanced Synovial Sarcoma

The FDA has accepted for priority review the BLA seeking the approval of afamitresgene autoleucel for the treatment of advanced synovial sarcoma.

United statesDennis williamsAdrian rawcliffeConnective tissue oncology societyStage developmentPrescription drug user fee actTissue oncology societyAnnual meetingLate stage developmentAdaptimmune therapeuticsAdvanced synovial sarcomaAfami celAfamitresgene autoleucelT cell therapyPhase 2 spearhead 1 trial2023 connective tissue oncology society ctos annual meeting

EMA Grants Orphan Drug Designation to Pimicotinib for Inoperable TGCT

The European Medicines Agency has granted orphan drug designation to pimicotinib for use as a potential therapeutic option in patients with inoperable tenosynovial giant cell tumor.

Connective tissue oncology societyConnective tissue oncology society annual meetingEuropean medicines agencyEuropean unionTissue oncology society annual meetingTissue oncology societyGlobal oncologyThe european medicines agencyNon small cell lung cancerInoperable tenosynovial giant cell tumorPimicotinib absk021

Monopar Therapeutics Reports Third Quarter 2023 Financial Results and Recent Developments

Monopar Therapeutics Reports Third Quarter 2023 Financial Results and Recent Developments
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Kimr tsuchimotoAnand jeyasekharan at national university of singaporeCompany nasdaqDevelopment rd expensesExchange commissionEncouraging preclinical results support further researchConnective tissue oncology societyNorthstar medical radioisotopesMonopar therapeutics incCamsirubicin phaseTrial efficacySafety data highlightedRadiopharmaceutical useFirst in human studyStart potentially as early decemberDose escalation trial

Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2023 Financial Results

Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2023 Financial Results
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United statesPankit vachhaniMastocytosis nonadvMastocytosis advChristi waarichPiper sandlerPrithviraj boseAndrew robbinsNeeta somaiahCogent biosciences incAmerican society of hematologyMd anderson cancer centerAmerican society of clinical oncologyCogent research teamConnective tissue oncology societyUniversity of alabama