Breakthrough Pace Shows No Signs Of Slowing
Executive Summary
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...
Keeping Track: FDA's Review Actions Carry On During Shutdown
The latest drug development news and highlights from our US FDA Performance Tracker.
Catalyst Stumbles With Filing Of Controversial 'Breakthrough Therapy' Firdapse
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.
Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116
As Merck’s 21-valent vaccine approaches its 17 June user fee goal, the US CDC’s vaccine committee is looking at new adult age-based recommendations and bracing for a full pipeline led by GSK’s 24-valent candidate.