- STAT+: FDA staff reiterate concerns about Replimune skin cancer treatmentRegulators at the FDA have reiterated concerns that Replimmune does not have adequate data to support an approval of its investigational skin cancer treatment.
- STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and moreThe FDA said a Capricor stem cell treatment for Duchenne muscular dystrophy did not meet a Phase 3 trial's objectives — contrary to company claims