It's CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News

It's CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News

Source: 
BioSpace
snippet: 

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.