FDA's drug center posted yet another record-breaking year for novel approvals, clearing 45 new molecular entities and therapeutic biologics, with big increases in orphan drug and breakthrough therapy approvals but few me-too drugs for common conditions. Is pharma's focus on unmet needs shortchanging public health?
Pharma followed the regulatory incentives to produce another record-breaking year for new drug approvals, leaving FDA's top new drugs official to wonder if the rush to invest in areas that qualify for expedited review is shortchanging important public health priorities.
FDA's Center for Drug Evaluation and Research cleared 45 new molecular entities and therapeutic biologics in 2015, exceeding the high...
There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
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.
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
