I-Mab And HI-Bio Announced An FDA Breakthrough Therapy Designation For Felzartamab For Primary Membranous Nephropathy
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I-Mab and HI-Bio have announced that the FDA has granted Breakthrough Therapy Designation for Felzartamab for the treatment of primary membranous nephropathy. This could potentially expedite the development and review process for the drug.

November 02, 2023 | 12:13 pm
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The FDA's Breakthrough Therapy Designation for Felzartamab could potentially expedite the development and review process for the drug, which could be beneficial for I-Mab.
The FDA's Breakthrough Therapy Designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). This could potentially lead to faster approval and commercialization of Felzartamab, which would be beneficial for I-Mab.
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