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...
A just-filed citizen petition requests that FDA not treat daily-wear uniform scrubs as medical devices.
FDA discusses the agencys surrogate endpoint (SE) table that was mandated by the 21st Century Cures Act of 2016.