Axsome Therapeutics steels itself for FDA rejection of migraine drug
According to the US health authority, Axsome Therapeutics has been unable to solve a number of problems with its manufacturing conditions for migraine candidate AXS-07, and as a consequence, the US-based firm is preparing for the drug’s final rejection.
by ulrich quistgaard, translated by daniel pedersen
An increase in Covid-19 cases delayed the US Food and Drug Administration’s (FDA) planned manufacturing site inspections of Axsome Therapeutics, which left the company waiting for answers for one of its pending candidates, as reported by industry media Fierce Biotech.
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