Results released Friday show itepekimab succeeded in one Phase 3 trial but failed in a second, sinking shares of both partner ...

Regeneron shares fell nearly 13% before the bell on Friday after its experimental drug for patients with a type of lung ...

The U.S. Food and Drug Administration has approved GSK's Nucala (mepolizumab) as an add-on maintenance treatment for adult ...

GSK plc (NYSE:GSK) has strengthened its market outlook following major regulatory milestones. The U.S. FDA’s recent approval ...

FDA approves Nucala as add-on therapy for COPD with high eosinophils, offering new hope by reducing flare-ups in patients ...

“Based on our latest discussions with the FDA, we continue to expect approval,” a GSK spokesperson said in an email. “The FDA is actively reviewing our submission for Nucala in COPD and we ...

Nucala is not currently approved for COPD treatment in any jurisdiction, but regulatory reviews were underway in the US, China and the European Union. Hospitalisation due to COPD remained a major ...

2 Nucala is not approved for the treatment of COPD in any country. Regulatory submissions are under review in several countries, including the US, China and the EU. The US FDA has provided a PDUFA ...

UK pharma major GSK (LSE: GSK) has published results from its Phase III MATINEE trial evaluating Nucala (mepolizumab) in patients with chronic obstructive pulmonary disease, as it awaits a US decision ...

Mepolizumab (Nucala) helped prevent exacerbations ... in a similar COPD population with an eosinophilic phenotype, leading to FDA approval. Dupilumab might be "better than mepolizumab at targeting ...

For example: In some cases, yes. Nucala is not approved by the Food and Drug Administration (FDA) to treat COPD. But the drug may be prescribed off-label for this use. (With off-label use ...

"If approved, mepolizumab could be the first biologic with monthly dosing for patients with COPD," the Company stated. First approved in 2015 for severe asthma with an eosinophilic phenotype in the US ...