Led by CBER Director Peter Marks, FDA is moving forward with policies that aim to improve access to gene therapies for patients with rare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how FDA plans to use regulatory policies to overcome barriers that are...

A “drive-by analysis of accelerated approval is intellectual malpractice,” argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues explain why a paper on the expedited regulatory pathway written by researchers at the Program on...

Vertex Pharmaceuticals' acquisition of Alpine Immune Sciences will bolster a growing kidney disease franchise that could help diversify Vertex’s business beyond its blockbuster cystic fibrosis franchise. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what attracted...