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FDA Approves IND Application for Brain Cancer Drug Candidate
americanpharmaceuticalreview
January 07, 2021
CNS Pharmaceuticals announced the Investigational New Drug (IND) application for its lead product candidate, Berubicin, for the treatment of Glioblastoma Multiforme (GBM) is now approved and in effect as filed with the US Food and Drug Administration ...
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CNS Pharmaceuticals Completes U.S. Manufacturing of Berubicin
contractpharma
October 22, 2020
Phase 2 trial will commence during the first quarter of 2021.
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CNS Achieves Key Milestones in Berubicin Dual-track Mfg. Strategy
contractpharma
September 07, 2020
CNS and Pii complete successful lab simulation of the lyophilization cycle and Pii is expected to begin manufacturing Berubicin during 3Q20.
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CNS Pharmaceuticals Completes API Shipments to Manufacturers
contractpharma
July 09, 2020
Supplies active ingredients for the production of Berubicin.
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FDA Grants Orphan Drug Designation for Brain Cancer Drug Berubicin
contractpharma
June 16, 2020
Accelerates its development to treat malignant gliomas and provides CNS with the potential for market exclusivity.
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CNS Announces Filing of Orphan Drug Designation for Brain Cancer Drug
americanpharmaceuticalreview
April 26, 2020
CNS Pharmaceuticals has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin.
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WPD Pharmaceuticals’ Brain Cancer Drug Received Positive FDA Pre-IND Guidance
americanpharmaceuticalreview
March 05, 2020
WPD Pharmaceuticals has provided an update that through its license partner, CNS Pharmaceuticals, it received positive feedback from the U.S. Food and Drug Administration (FDA) for its Pre-IND ...