The relabeling of Aransep and Procrit to address safety issues is taking longer than expected. There's nothing new about that. What is new is how FDA weighed in on the Congressional debate over coverage for the anemia therapies-and how the last step of the regulatory process is likely to play out.
By Michael McCaughan
Whoever said actions speak louder than words hasn’t been paying attention to the regulatory response to drug safety issues involving...
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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.
