EU drug regulator finds no safety signals either
Final decision due in days
Spikevax gets biologics license application (BLA)
Signs license agreement with Hikma
High efficacy, favourable safety profile in Phase 3 trial
At the Food and Drug Administration
Extra dose provides great protection
In the United States
Green-light by FDA warmly welcomed.
U.S. FDA rejects application by Allergan.
August is the new date.