FDA Issues Refusal-to-File Letter to Alkermes for Depression Treatment


On April 2, 2018, Irish biotech Alkermes revealed that it had received a Refusal-to-File letter from the FDA regarding its depression drug ALKS 5461. The announcement caused Alkermes shares to drop 22.4%, and adversely affected the performance of biotech stocks and exchange-traded funds on Monday.



from Biotech News