GC012F, CAR-T Cell Therapy Candidate, Granted FDA Orphan Drug Status

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GC012F, CAR-T Cell Therapy Candidate, Granted FDA Orphan Drug Status
November 30, 2021November 30, 2021
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Gracell Biotechnologies’ investigational new treatment for multiple myeloma, GC012F, has been named an orphan drug by the U.S. Food and Drug Administration (FDA). Orphan drug status is intended to encourage the development of therapies for rare diseases affecting fewer than 200,000 people in the U.S. It provides benefits and incentives, including exemption from FDA application fees, assistance in clinical trial design, and seven years of market exclusivity if eventually approved. “We are very excited about…

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