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You are here: Industry Insights > ALKS 5461

News List

FDA accepts NDA for ALKS 5461 for major depressive disorder europeanpharmaceuticalreview
April 25, 2019
The FDA has accepted for review the New Drug Application for ALKS 5461, a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder …
Committee advises against FDA approval of Alkermes' novel depression drug pharmafile
November 19, 2018
Alkermes has been knocked back with the disappointing, though not entirely unexpected, news that the FDA-appointed Psychopharmacologic Drugs Advisory
FDA advisors turn down Alkermes’ ALKS 5461 pharmatimes
November 05, 2018
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).
Will third trial be the charm for Alkermes' depression drug? fiercebiotech
August 22, 2017
Alkermes hopes the drug could help millions of people with resistant depression.