FDA approves Alkermes’ Lybalvi for schizophrenia and bipolar I disorder
Alkermes said that it is expecting to make Lybalvi available for patients in the fourth quarter of 2021
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Tag: Alkermes
FDA rejects Alkermes’ depressive disorder drug
The US Food and Drug Administration (FDA) has rejected Alkermes’ filing for ALKS 5461 in major depressive disorder (MDD), asking for more clinical data.
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Alkermes and Biogen announce new MS drug application for FDA
Alkermes has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for experimental multiple sclerosis (MS) drug diroximel fumarate.
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FDA advisors turn down Alkermes’ ALKS 5461
Alkermes’ ALKS 5461 has been hit with a potential setback in the US after regulatory advisors failed to back its approval for major depressive disorder (MDD).
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Alkermes licences experimental MS therapy to Biogen
Dublin, Ireland-based Alkermes has licensed ALKS 8700, a novel, oral, small drug molecule in Phase III development for relapsing forms of multiple sclerosis, to US biotech Biogen.
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Alkermes boosted by trial success for antidepressant
Shares in Ireland-headquartered Alkermes shot up nearly 50 percent after its experimental depression drug hit targets in a pivotal late-stage trial.
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