Ube Industries, Ltd.

A beneficial effect of sponsorship by the largest companies in the pharma industry can be seen in the fates of novel agent applications that faced US FDA approval decisions in recent years: the applic

A beneficial effect of sponsorship by the largest companies in the pharma industry can be seen in the fates of novel agent applications that faced US FDA approval decisions in recent years: the applic

New molecular entities had a rough week at the US FDA, as the agency issued a complete response letter for Gilead Sciences, Inc. ’s bulevirtide for hepatitis delta virus infection, CytoDyn, Inc. wi

Two of the US FDA’s latest new product approvals, Santen Pharmaceutical Co., Ltd. ’s Omlonti and Fennec Pharmaceuticals Inc. ’s Pedmark, both overcame manufacturing-related complete response letters