After suffering a complete response letter a little over a month ago, Alkermes quickly sorted out the manufacturing shortfalls that blighted its experimental med—and now, the FDA has set a potential approval date this summer.
It’s been a rollercoaster 18 months for Alkermes, which ended 2019 by axing staffers and cutting spending after its depression drug ALKS 5461 was rejected earlier in the year.
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