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FDA approves Aristada Inito for the initiation of Aristada for schizophrenia europeanpharmaceuticalreview
July 05, 2018
Novel regimen enables physicians to fully dose up to two months of Aristada treatment on day one…
FDA flip-flops on Alkermes' drug application pharmafile
April 18, 2018
Two weeks ago, it looked like the hopes for Alkermes’ ALKS 5461 receiving approval would rely on returning to the clinic to undergo the lengthy process of gathering more data on the drug, after it received a Refuse to File letter from the FDA.
Alkermes Gains NDA Acceptance for MDD Treatment That was Previously Rejected by the FDA biospace
April 17, 2018
In a stunning about-face the U.S. Food and Drug Administration (FDA) has accepted Alkermes New Drug Application (NDA) for ALKS 5461, a treatment for major depressive disorder, the company announced this morning. The FDA rejected the NDA at the end of Marc
Alkermes licences experimental MS therapy to Biogen pharmatimes
November 30, 2017
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.
Biogen Forges $278M MS Tie-Up With Alkermes biospace
November 28, 2017
Biogen and Alkermes Announce License and Collaboration Agreement to Develop and Commercialize ALKS 8700 for the Treatment of Multiple Sclerosis

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