SHINKEI THERAPEUTICS ANNOUNCES INVESTIGATIONAL NEW DRUG APPLICATION SUBMISSION FOR MR-201, A NOVEL DOSAGE FORM FOR TREATMENT OF PSEUDOBULBAR AFFECT
August 21st
, 2019
PRINCETON, N.J., August 21st
, 2019 -- SHINKEI Therapeutics, a clinical stage pharmaceutical
company focused on the development of drugs for the treatment of Central Nervous System
(CNS) disorders, today announced the filing of an Investigational New Drug ("IND") application
with the U.S. Food and Drug Administration ("FDA") of MR-201, a novel dosage form for the
treatment of Pseudobulbar Affect (PBA).
FDA ACCEPTS SHINKEI THERAPEUTICS INVESTIGATIONAL NEW DRUG APPLICATION FOR MR-301 FOR TRAUMATIC BRAIN INJURY
August 27th, 2019
PRINCETON, N.J., August 27, 2019 (GLOBE NEWSWIRE) -- SHINKEI Therapeutics., a clinical stage pharmaceutical company focused on the development of therapeutic drugs for the treatment of Central Nervous System (CNS) disorders, today announced that they received notification from Food and Drug Administration (FDA), stating that FDA has accepted the filing of an Investigational New Drug ("IND") application for MR-301 for the treatment of Severe Traumatic Brain Injury (sTBI) resulting in minimally conscious and/or vegetative comatose state.
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