Community Update: FDA accepts to review Biologics License Application for apitegromab
FDA accepts to review Biologics License Application for apitegromab
Scholar Rock announced that the FDA has accepted to review its Biologics License Application for apitegromab, with a decision expected by 30 September 2026 (Prescription Drug User Fee Act action date).
In Europe, the Marketing Authorisation Application for apitegromab remains under review by the EMA, with a decision expected around mid-2026.