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Maroc Maroc - ZACKS.COM - All Stories - 20/Aug 14:18

GSK's ADC Drug for Lung Cancer Gets FDA's Breakthrough Tag

The FDA bestows a Breakthrough Therapy Designation to GSK's B7-H3-targeted antibody-drug conjugate, GSK5764227, for relapsed/refractory extensive-stage small-cell lung cancer.

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The Johnson & Johnson filing seeks the FDA's approval for nipocalimab to treat generalized myasthenia gravis in a broad population of...

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Corvus Stock Up on Initiation of Phase III Lymphoma Study on Lead Drug

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CRVS stock gains 14% on initiating a registrational study on its lead candidate, soquelitinib, to treat relapsed/refractory peripheral T-cell...

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ILMN's TSO Comprehensive IVD Test Secures FDA Approval as CDx

zacks.com - 28/Aug 16:59

Illumina's cancer biomarker test, TSO Comprehensive, gets approved by the FDA for use as CDx to match patients with targeted therapies.

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Summit Hits Record High on Lung Cancer Drug Topping Merck's Keytruda

zacks.com - 10/Sep 16:20

Data from a late-stage study shows that SMMT's experimental antibody beat Keytruda in a head-to-head setting in treating certain patients with NSCLC.

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ITRM Posts Updates From FDA Advisory Meeting for UTI Drug, Stock Down

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Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.

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Ifinatamab Deruxtecan Continues to Demonstrate Promising Objective Response Rates in Patients with Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial

drugs.com - 07/Sep 06:09

BASKING RIDGE, N.J. & RAHWAY, N.J., September 7, 2024 – Results from an interim analysis of the dose-optimization part of the ongoing IDeate-Lung01...

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Ifinatamab Deruxtecan Continues to Demonstrate Promising Objective Response Rates in Patients with Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial

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SWTX's NDA for Rare Tumor Drug Gets Priority Review From FDA

zacks.com - 29/Aug 15:52

The FDA accepts and grants priority review to SpringWorks' NDA for mirdametinib for treating neurofibromatosis type 1-associated plexiform...