Did GSK's Nucala Trials In COPD Strengthen Confidence In The Eosinophil Biomarker?
US FDA was hoping Pulmonary-Allergy Drugs Advisory Committee could help provide some clarity on its use, but there still are many questions.
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Keeping Track: J&J Esketamine, Sanofi Caplacizumab Lead Off September Submissions; US FDA Says No To Nucala
The latest drug development news and highlights from our US FDA Performance Tracker.
Unclear data on monoclonal antibody's efficacy caused many members of Pulmonary-Allergy Drugs Advisory Committee to vote against recommending approval.
US FDA advisory committee will consider impact of trial design, given that GSK did not collect asthma histories and chronic oral corticosteroid use information from its COPD study participants.