US FDA's Record-Breaking Month Of Breakthrough Therapy Designations
Alnylam's ALN-AS1 became the eighth announced therapy to receive a breakthrough designation in May 2017, breaking the previously monthly high of seven.
You may also be interested in...
US FDA granted designations for several products based on late-stage data; with at least 19 breakthrough therapy designations, five-year-old program sets another record in first quarter of 2018.
Keeping Track: A Burst of CRLs and BTDs, A Busy Week Of Submissions And Another Approval For Soliris
The latest drug development news and highlights from our US FDA Performance Tracker.
Sponsors are seeking US “Breakthrough Therapy” Designations at a record pace in FY 2017.