November 1, 2018 04:33 PM EDTUpdated April 22, 12:17 PM

FDA experts gun down Alkermes’ pitch for ALKS-5461, slamming the company on multiple fronts

John Carroll

Editor & Founder

A large group of outside experts at the FDA has slapped down Alkermes’ campaign to gain an approval for their depression drug ALKS-5461, objecting to …

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FDA experts gun down Alkermes’ pitch for ALKS-5461, slamming the company on multiple fronts

John Carroll

Editor & Founder

Sign up to read this article for free.

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FDA ex­perts gun down Alk­er­mes’ pitch for ALKS-5461, slam­ming the com­pa­ny on mul­ti­ple fronts

John Carroll

Editor & Founder

Sign up to read this article for free.

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FDA experts gun down Alkermes’ pitch for ALKS-5461, slamming the company on multiple fronts

The Endpoints 2024 winners and losers list: Who was up and who was down in biopharma

Updated: Novo’s 23% weight loss with CagriSema falls short of high expectations, new trial planned

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Accelerated approval brings Pfizer's BRAF inhibitor to first-line patients

Exclusive: Florida cancer biotech raises $100M Series A

Califf, on his way out at FDA, predicts agency tug-of-war between Ramaswamy and RFK Jr.