FDA grants Spark Biomedical a Breakthrough Device Designation for the Roo System: a transcutaneous electrical nerve stimulator that aids in reducing s...
Some 20 Senate Democrats ask Operation Warp Speed leaders for answers to questions about the governments decision not to exercise its option to purcha...
Mesoblast says its rexlemestrocel-L reduced cardiac mortality in a Phase 3 trial of patients with advanced chronic heart failure.
The ACLU again criticizes the Trump administration and FDA for requiring patients seeking access to the abortion pill to go to a health center to sign...
FDA releases its latest batch of Warning Letters that include JC Ayur Life and Desert Alchemist.
FDA approves a Foldax IDE to begin a clinical study of its Tria biopolymer mitral surgical heart valve.
FDA grants Gannex a fast track designation for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42, which the company describes as a novel n...
FDA approves a shorter two-hour infusion time for Genentechs Ocrevus (ocrelizumab) dosed twice-yearly for those living with relapsing or primary prog...