Tag : approval

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OncoImmune Announces Approval of IND Application for ONC-392 – The anti-CTLA-4 Antibody that Preserves CTLA-4 Recycling for Better Safety and Efficacy

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ROCKVILLE, Md.–(BUSINESS WIRE)–OncoImmune, Inc. announced today that its Investigational New Drug (“IND”) application for ONC-392, its novel, next generation anti-CTLA-4 antibody, has been approved by...
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Tandem Diabetes snags FDA approval for interoperable insulin pump software

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Tandem Diabetes’ technology will create a new approval pathway for predictive dosing software that can be used with other devices. Source link...
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AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Clinical Feasibility Study to Evaluate RECELL System for Vitiligo

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VALENCIA, Calif. & MELBOURNE, Australia–(BUSINESS WIRE)–AVITA Medical Limited (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical...
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Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval

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FOSTER CITY, Calif. & TOKYO–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan) announced today that Gilead Sciences K.K. (Tokyo, Japan) and...

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