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FDA Grants Fast Track Designation To CNS's Berubicin For Glioblastoma Multiforme Treatment

The U.S. Food and Drug Administration granted Fast Track Designation for CNS Pharmaceuticals Inc.'s (CNSP) lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme or GBM.

The Fast Track Designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.

CNS recently announced the start of patient enrollment in its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme.

The company had also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.

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