Breakthrough Pace Shows No Signs Of Slowing
FDA started off 2016 with a spate of new breakthrough therapy designations, feeding the popular program – and fueling agency concerns about workforce strain.
You may also be interested in...
The latest drug development news and highlights from our US FDA Performance Tracker.
FDA’s refuse-to-file letter for Firdapse in two ultra-rare neuromuscular disorders does not make judgments about the drug’s safety or efficacy, says Catalyst.
Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker