ALL
Pharma in China
Pharma Experts
Market News
Products Guide
Brand Story
-
FDA accepts NDA for ALKS 5461 for major depressive disorder
April 25, 2019The 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
November 19, 2018Alkermes 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
November 05, 2018Alkermes’ 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?
August 22, 2017Alkermes hopes the drug could help millions of people with resistant depression.
Pharma Sources Insight January 2025
