The U.S. Food and Drug Administration is quickly catching up after COVID-19 disrupted typical review timelines and planned inspections and it's bad news for three companies. Junshi Biosciences and Coherus Biosciences received a Complete Response Letter (CRL) after applying for commercialization of their star biologic, while Axsome Therapeutics received a CRL for its acute migraine treatment, AXS-07.
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