An additional three months of exclusivity would be awarded for a company's second round of pediatric studies under a proposed amendment to Sen. Hillary Rodham Clinton's (D-N.Y.) bill to codify FDA's mandatory pediatric study rule

Lack of official explanation about how the exchange of critical information will progress pending the launch of the EU’s medical device database, Eudamed3, has left many confused. New guidance lights the way forward.

From relatively little-known to high-flying, hotly pursued targets by global pharma players, Chinese domestically developed immuno-oncology drugs are ascending in both value and attractiveness, both inside China and far beyond.