Big Pharma's Winning Formula: Many Approvals, Narrow Markets
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?
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US FDA's argument that its review resources favor novelty/medical advances could be buttressed by Tufts Center for the Study of Drug Development analysis of (less novel) approvals using the streamlined 505(b)(2) NDA pathway.
The latest drug development news and highlights from our FDA Performance Tracker.
FDA’s top new drug official called out industry’s innovation model, noting that major primary care markets are being left underserved as sponsors focus on precision medicine and rare diseases.