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Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel) | National Business

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Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel) | National Business

SOMERSET, N.J.–(BUSINESS WIRE)–Jun 6, 2023– Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). The sBLA seeks to expand the label for CARVYKTI ® … [Read more…]

Therini Bio Initiates First-In-Human Dosing in Phase 1 Trial of THN391, a Fibrin-Targeting Therapeutic Candidate for Alzheimer’s Disease | National Business

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Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel) | National Business

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–May 15, 2023– Therini Bio, Inc., a biotech company focused on developing fibrin-targeted therapies to treat inflammatory neurodegenerative and retinal diseases, today announced the initiation of first-in-human dosing for a Phase 1 trial of its lead asset THN391, a fibrin-targeting therapeutic candidate for Alzheimer’s disease. THN391 binds to the inflammation-driving component … [Read more…]