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 ...

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

Mepolizumab has had a bumpy road to arriving at its indication in COPD. An FDA advisory committee in 2018 declined to ...

The FDA has approved Nucala (mepolizumab) as an add-on maintenance treatment for certain COPD patients whose disease isn't ...

The U.S. Food and Drug Administration has approved British drugmaker GSK's asthma drug to treat some patients with a chronic ...

The FDA has granted approval to GSK's Nucala as an add-on maintenance treatment for adult patients suffering from inadequately controlled COPD.

The Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD ...

The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD ...

“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 ...