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Regulation

Oct. 1 Quick Takes: Setback at FDA for Mesoblast; plus AMAG, Solid, COVID updates from Gilead, AZ and more 

Oct 2, 2020 | 2:36 AM GMT

Bucking ODAC recommendation, FDA wants another trial from Mesoblast
Mesoblast Ltd. (ASX:MSB; NASDAQ:MESO) said FDA issued a complete response letter to a BLA for remestemcel-L to treat pediatric steroid-refractory acute GvHD. FDA’s Oncologic Drugs Advisory Committee had voted 9 to 1 to back approval of the therapy, but the company said FDA wants

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