A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
The FDA greenlit GlaxoSmithKline’s Nucala (mepolizumab) for treating severe eosinophilic asthma in children as young as 6 years.
Sanofi SA’s eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.
AstraZeneca released positive results from the BORA Phase III extension clinical trial of Fasenra (benralizumab) as an add-on maintenance therapy in patients with severe eosinophilic asthma that had already completed either the SIROCCO or CALIMA Phase III trials.
Amgen and AstraZeneca announced that the U.S. FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype.
AstraZeneca’s first respiratory biological medicine Fasenra failed to meet its main target in a second clinical trial treating patients with moderate to very severe chronic obstructive pulmonary disease (COPD).