Expedited Review Pathways: Three More Breakthroughs, Third RMAT Awarded
US FDA's popular breakthrough therapy designation given to Proteon's vonapanitase for dialysis patients, Synthetic Biologics' ribaxamase to prevent C. difficile infection, and River Vision's teprotumumab for thyroid eye disease; Vericel's cell therapy for heart failure is designated a regenerative medicine advanced therapy.
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Synthetic Biologics emerged from meetings with US FDA without its breakthrough designation, but with hope that agency will allow decoupling of safety and efficacy endpoints in planned Phase III trial for prevention of C. difficile infection.
The latest drug development news and highlights from our US FDA Performance Tracker.
Day three at the BIO International Convention included an off-site visit to Lilly's newly expanded R&D site as well as conversations with Sigilon about the $23m Series A venture funding round it announced that morning and with CytomX about its dealmaking strategy.