Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Big Pharma's Winning Formula: Many Approvals, Narrow Markets

Executive Summary

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?


Related Content

Keeping Track: CDER 2016 Novel Approvals Hold At 22 As US FDA Declines Cempra's Solithera
More Me-Too Drugs Please, FDA’s Jenkins Asks Industry