User fee revenue expected to break $1bn threshold by FY 2020, but growth looks to be slower than last few years.
Industry may be expecting FDA to slow the annual increases in its prescription drug user fee collections during the next program cycle.
A fee structure change and initial revenue estimate suggest a lower rate of increase in fee revenue for FDA than...
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.
