On August 26, 2022, the Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth […]
Docket Number: FDA-2022-D-1503 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guideline describes science and risk-based approaches for […]
Docket Number: FDA-2022-D-1527 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guideline provides recommendation to promote a consistent […]
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