FDA approves Akeso’s monoclonal antibody for nasopharyngeal carcinoma
The approval is supported by the outcomes from the AK105-202 trial and the Phase III study. AK105-304.
Approvals
EC grants orphan drug designation to Dyne Therapeutics’ DMD therapy
Biogen’s Friedreich’s ataxia treatment authorised in UK
FDA grants breakthrough status to uniQure’s Huntington’s disease therapy
UK’s MHRA authorises GSK’s Blenrep for multiple myeloma treatment
Sanofi and Regeneron’s dupilumab approved by FDA for urticaria
FDA approves Neurelis’ nasal spray for seizures
EC authorises Eisai and Biogen’s lecanemab for Alzheimer’s
