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The U.S. Food and Drug Administration has approved British drugmaker GSK's asthma drug to treat some patients with a chronic ...
The COPD approval marks the fifth Nucala has received from the FDA, following green lights in severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis and ...
GSK (NYSE:GSK) announced Thursday that the U.S. FDA has further broadened the label for its asthma therapy, approving the ...
Patients were randomised 1:1 to receive Nucala 100mg or placebo subcutaneously every four weeks in addition to standard ...
The U.S. Food and Drug Administration has approved British drugmaker GSK's asthma drug to treat some patients with a chronic ...
FDA approves mepolizumab (Nucala; GSK) as the first monthly biologic for chronic obstructive pulmonary disease (COPD), significantly reducing exacerbations in patients with an eosinophilic phenotype.
GSK’s (LSE: GSK) biologic therapy Nucala (mepolizumab) has demonstrated a consistent reduction in exacerbation rates among ...
Nucala, an anti–interleukin-5 (IL-5) monoclonal antibody developed by GSK, was associated with a sustained reduction in emergency department (ED) visits, hospitalisations, and symptom burden for ...
The missed PDUFA adds to a string of delays at the FDA in recent weeks, including at least two other missed target action ...
GSK had expected to secure an FDA nod for its IL-5 antibody Nucala in chronic obstructive pulmonary disease (COPD) on Wednesday, but the May 7 deadline has come and gone without a decision from ...
Nucala (mepolizumab) delivers clinically meaningful and statistically significant reduction in COPD exacerbations, with positive MATINEE trial results published in New England Journal of Medicine ...
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