EMA to review Dynax Heplisav marketing authorization application
Heplisav is indicated for immunization against infection caused by all known subtypes of hepatitis B virus in people aged 18 through 70 years of age and in patients
The US Food and Drug Administration (FDA) has granted rare paediatric disease designation to Vanda Pharmaceuticals’ VCA-894A, an investigational antisense oligonucleotide therapy for Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S).