The #FDA has extended its review of #Novo's experimental #haemophiliaA drug #denecimig because of ongoing remediation work at a facility that will be used to manufacture the #FactorVIIIamimetic.
@pharmaphorum.bsky.social
@pharmaphorum.bsky.socialThe #FDA has extended its review of #Novo's experimental #haemophiliaA drug #denecimig because of ongoing remediation work at a facility that will be used to manufacture the #FactorVIIIamimetic.
@4040rec.bsky.social@pharmaphorum.bsky.social#Novo has moved a step closer to #EU approval of its long-acting #haemophiliaA therapy, #Frehemgo, after it was backed by the #EMA's human medicines committee.