Progenics Pharmaceuticals, Inc.

Efforts to create an ultra-rare disease designation and related incentives seem to have hit a roadblock at the US Food and Drug Administration. Two prominent FDA officials, who oversee many of its rar

The US Food and Drug Administration’s approval of Amgen, Inc. ’s Lumakras (sotorasib) stood out even in a noteworthy week for the agency, which also saw approval of a novel imaging agent, a new women

With the approval of BioCryst Pharmaceuticals, Inc. ’s Orladeyo (berotralstat) on 3 December 2020, the US FDA’s Center for Drug Evaluation and Research matched the full-year novel approval count from

Hutchison China MediTech Ltd. (Chi-Med) has further strengthened its position for its first planned independent launch in China, after a second trial with anticancer surufatinib was stopped early aft