BIO was as busy as ever in Boston this year. With more to come soon, here are a few initial thoughts on three events I ...

A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy ...

According to an internal email, the agency may be in for more consolidation in areas including human resources, ...

GSK has licensed altSonflex1-2-3, its Shigella vaccine candidate, to Bharat Biotech for the continued development and distribution.

The U.S. Food and Drug Administration has approved GSK's Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary ...

Nucala is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. Nucala has been developed for the treatment of a range of ...

FRIDAY, May 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled ...

Nucala stands out as the only approved biologic that has been specifically evaluated in patients whose eosinophilic phenotype is defined by a blood eosinophil count (BEC) threshold as low as ≥ ...

GSK has received approval from the US Food and Drug Administration (FDA) for its monoclonal antibody, Nucala (mepolizumab).

Approval of Nucala marks the first biologic approved for chronic obstructive pulmonary disease patients with blood eosinophil counts as low as ≥150 cells/μL. The FDA has approved GSK’s Nucala ...

Nucala (generic name mepolizumab) works alongside inhalers. “COPD isn’t just a disease, it’s a relentless cycle,” said Jean Wright, MD, chief executive officer of the COPD Foundation, ...