FDA's new drug safety authorities suggest that the focus of drug development and lifecycle management strategies need to change. It is no longer a question of what it takes to get approval from FDA, but rather what kind of approval you can get.
By Michael McCaughan
Editor’s Note: This analysis is adapted from a webinar hosted by The RPM Report and Ropes & Gray. A recorded...
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While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
