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Ceribell Gains FDA Clearance For New EEG Monitoring Software

posted: Wed, 09/30/2026 - 08:55 EDT

by: Nasdaq News

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AEON Gains FDA Feedback On ABP-450 Biosimilar Pathway

posted: Wed, 09/30/2026 - 08:37 EDT

by: Nasdaq News

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Immunome's IM-1340 Receives FDA IND Clearance For Advanced Solid Tumors

posted: Wed, 09/30/2026 - 08:11 EDT

by: Nasdaq News

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Tiziana Seeks FDA Orphan Drug Designation For Intranasal Foralumab

posted: Wed, 09/30/2026 - 07:52 EDT

by: Nasdaq News

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Roche Gets FDA Filing Acceptance For Fenebrutinib In MS; Launches Newborn Screening Test

posted: Wed, 09/30/2026 - 02:58 EDT

by: Nasdaq News

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Genentech: FDA Grants Priority Review To Fenebrutinib NDA For Relapsing And Primary Progressive MS

posted: Wed, 09/30/2026 - 01:37 EDT

by: Nasdaq News

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DBV Seeks FDA Approval For VIASKIN Peanut Patch In Young Children

posted: Wed, 09/30/2026 - 01:20 EDT

by: Nasdaq News

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Unicycive Resubmits OLC NDA With New Manufacturing Data To Support FDA Review; Stock Down

posted: Tue, 09/29/2026 - 09:42 EDT

by: Nasdaq News

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Unicycive Therapeutics Resubmits Oxylanthanum Carbonate NDA To FDA

posted: Tue, 09/29/2026 - 09:04 EDT

by: Nasdaq News

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BeyondSpring Gets FDA Fast Track For Plinabulin In Lung Cancer

posted: Tue, 09/29/2026 - 07:36 EDT

by: Nasdaq News

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Biotech Stocks Facing FDA Decision In October 2026

posted: Tue, 09/29/2026 - 05:33 EDT

by: Nasdaq News

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Teva Pharma Secures FDA Nod For DEGEVMA, A Biosimilar To Xgeva

posted: Tue, 09/29/2026 - 02:26 EDT

by: Nasdaq News

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SI-BONE Gets FDA 510(k) Clearance For IFuse Granite Onyx In Spinal Fusion

posted: Tue, 09/29/2026 - 01:43 EDT

by: Nasdaq News

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Egetis Therapeutics' EMCITATE Wins FDA Approval For MCT8 Deficiency

posted: Tue, 09/29/2026 - 01:38 EDT

by: Nasdaq News

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HUTCHMED Seeks FDA Approval For ORPATHYS-TAGRISSO In Resistant Lung Cancer

posted: Mon, 09/28/2026 - 23:56 EDT

by: Nasdaq News

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