Posts

FDA Staff Signal Replimune RP1 Melanoma Trial Failure, Slashing Stock

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Capricor Shares Plunge After FDA Says DMD Therapy Lacks Efficacy Ahead of Advisory Committee Meeting

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Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues

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UniQure stock surges after FDA U-turn clears path to gene therapy filing

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Can Intellia's lonvo-z Turn CRISPR Promise into HAE Practice?

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ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease

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Candel Therapeutics reports strong long‑term prostate cancer data ahead of FDA filing

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Capricor Shares Rise as FDA Sets August 2026 Decision Date for Deramiocel in Duchenne Muscular Dystrophy After Prior Rejection

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Ultragenyx Resubmits BLA for UX111 Gene Therapy with New Long-Term Data for Sanfilippo Syndrome Type A

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Ultragenyx Resubmits BLA for UX111 Gene Therapy Targeting Sanfilippo Syndrome Type A to FDA

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MoonLake revives FDA push

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MoonLake revives FDA push

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MoonLake revives FDA push

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MoonLake revives FDA push

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MoonLake revives FDA push

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Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA

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Outlook Therapeutics Faces New FDA Setback for First Ophthalmic Avastin Formulation

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