Enobia Pharma's ENB-0040 receives FDA fast-track designation (The Canadian Press via Yahoo! Canada News)
MONTREAL - The U.S. Food and Drug Administration has granted fast-track status for an enzyme replacement therapy being developed by Enobia Pharma as a treatment for a potentially life-threatening bone disease.

AdvanDx Receives FDA 510(k) Clearance For GBS PNA FISH(R) For Rapid Detection Of Group B Strep From Lim Broths (Medical News Today)
AdvanDx announced it received FDA 510(k) clearance for GBS PNA FISH for detection of Streptococcus agalactiae, aka Group B Strep, from turbid Lim Broths inoculated with vaginal and rectal swabs obtained from pregnant women between 35 and 37 weeks gestation.