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FDA Pushes Review Of BioXcel's Candidate For Agitation Associated With Neuropsychiatric Disorders
Wednesday, December 1, 2021 - 12:08pm | 249Read More...The FDA has extended the review period for BioXcel Therapeutics Inc's (NASDAQ: BTAI) marketing application seeking approval for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II. In connection with the FDA's...
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Alkermes Shares Move Higher On FDA Approval Of Schizophrenia, Bipolar Med
Tuesday, June 1, 2021 - 9:35am | 153Read More...The FDA has approved Alkermes plc's (NASDAQ: ALKS) Lybalvi, a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity, for schizophrenia and bipolar I disorder. The approval comes as a maintenance...
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BioXcel's Formulated Dexmedetomidine US Application For Agitation Under FDA Review
Wednesday, May 19, 2021 - 8:11am | 206Read More...The FDA has accepted for review, BioXcel Therapeutics Inc's (NASDAQ: BTAI) marketing application for BXCL501, an orally dissolving thin film formulation of dexmedetomidine. The application covers the acute treatment of agitation associated with schizophrenia and bipolar...
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Intra-Cellular Therapies Files US Application For Expanded Use Of Lumateperone In Bipolar Settings
Monday, February 22, 2021 - 2:15pm | 159Read More...Intra-Cellular Therapies Inc (NASDAQ: ITCI) submits CAPLYTA (lumateperone) supplemental marketing application to the FDA to treat depressive episodes associated with bipolar I or II disorder in adults. The application seeks approval for two indications of CAPLYTA; as...
