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Ivosidenib as Monotherapy Granted FDA Approval for Certain Patients with IDH1 Mutant AML

17:13 EDT 2 May 2019 | Pharmacy Times

The sNDA was granted Priority Review and accepted under the agency's Real-Time Oncology Review pilot program, which aims to make the review of oncology drugs more efficient by allowing the FDA access to clinical trial data before the information is formally submitted to the agency.

Original Article: Ivosidenib as Monotherapy Granted FDA Approval for Certain Patients with IDH1 Mutant AML

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