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FDA sNDA: Servier’s TIBSOVO® to Treat Acute Myeloid Leukemia

FDA sNDA: Servier’s TIBSOVO® to Treat Acute Myeloid Leukemia

Mar 7, 2022 | FDA, News, Regulatory

Servier has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for TIBSOVO® (ivosidenib tablets) in combination with azacitidine to potentially treat patients with previously untreated...
FDA Grants ODD Status to SEL24/MEN1703 for Treatment of AML

FDA Grants ODD Status to SEL24/MEN1703 for Treatment of AML

Nov 4, 2021 | FDA, News, Pharmaceuticals, Regulatory

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to SEL24/MEN1703, an orally available, dual PIM/FLT3 inhibitor designed for the treatment of Acute Myeloid Leukemia (AML). Licensed by the Menarini group from Ryvu Therapeutics,...
Acute Lymphoblastic Leukemia (ALL): First Approved CAR T-Cell

Acute Lymphoblastic Leukemia (ALL): First Approved CAR T-Cell

Oct 4, 2021 | News, Regulatory

The US FDA (Food and Drug Administration) has approved the first-ever chimeric antigen receptor (CAR) T-cell therapy, brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company) for adults with relapsed or refractory acute lymphoblastic leukemia (ALL). The approval...
FDA Grants Fast Track Designation to Syndax Pharmaceuticals

FDA Grants Fast Track Designation to Syndax Pharmaceuticals

Jun 28, 2021 | News, Regulatory

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Syndax Pharmaceuticals for the treatment of relapsed/refractory acute leukemia with either MLLr or NPM1 mutations called SNDX-5613. Previously, SNDX-5613 was granted Orphan Drug...
PMDA Grants Regulatory Approval for Leukemia Drug Therapy

PMDA Grants Regulatory Approval for Leukemia Drug Therapy

Jun 24, 2021 | News, Regulatory

Japan’s regulatory body, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), has granted HUYABIO International, Shenzhen Chipscreen Biosciences’ licensing partner, regulatory approval for leukemia drug therapy, Tucidinostat. Tucidinostat, also...

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