Biotech pulls plans to file accelerated approval after FDA 'change in direction' — shares plummet

Amber Tong

When the FDA lifted a clinical hold on Applied Therapeutics’ lead program in galactosemia last February, the New York biotech signaled that they were …

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Biotech pulls plans to file accelerated approval after FDA 'change in direction' — shares plummet

Amber Tong

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Updated: Amgen obesity shot shows 20% weight loss, but dosing questions hang over readout

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Biotech pulls plans to file ac­cel­er­at­ed ap­proval af­ter FDA 'change in di­rec­tion' — shares plum­met

Amber Tong

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