Eosinophilic Asthma Archives

A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.

FDA Approves GSK’s Nucala for Children with Severe Eosinophilic Asthma

Approvals, Biologics, Children, Chronic Obstructive Pulmonary Disease (COPD), Clinical Data, FDA, FDA/Regulatory, Severe Eosinophilic Asthma

The FDA greenlit GlaxoSmithKline’s Nucala (mepolizumab) for treating severe eosinophilic asthma in children as young as 6 years.

Tezepelumab Granted Breakthrough Therapy By FDA

Biomarkers, Breakthrough Therapy Designation, Clinical Trials, Collaboration, Eosinophilic Phenotype, FDA/Regulatory, First-In-Class, Inflammation, R&D, Severe Asthma

Amgen and AstraZeneca announced that the U.S. FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype.