The FDA has accepted for review the BLA for mepolizumab as an add-on maintenance treatment for eosinophilic COPD.

The US Food and Drug Administration (FDA) has accepted a submission from GSK to review a new indication of Nucala ...

After previously rejecting an application for this indication, the US Food and Drug Administration (FDA) has now accepted for ...

British drug maker GSK plc (GSK, GSK.L) announced Monday that the U.S. Food and Drug Administration has accepted for review, data ...

GSK plc GSK announced that the FDA has accepted its regulatory filing, seeking the approval of a new indication for Nucala ...

US FDA accepts GSK’s submission for the use of Nucala to treat patients with chronic obstructive pulmonary disease: London, UK Wednesday, December 11, 2024, 10:00 Hrs [IST] GSK ...

Committee members voted on the basis of data presented and concluded that the risk-benefit profile for Nucala (mepolizumab) was not sufficient to support approval - three voted for; 16 against.

GlaxoSmithKline is eyeing another indication for its Nucala (mepolizumab) biologic drug after a phase 3 trial in inflammation caused by nasal polyps hit its targets, bringing it into competition ...

GSK (NYSE:GSK) announced Friday that its asthma therapy Nucala (mepolizumab) reached the main goal in a Phase 3 trial for ...

GSK (GSK) announced the US Food and Drug Administration, FDA, has accepted for review, data from the MATINEE study to support the regulatory ...

GSK has received approval from the China National Medical Products Administration for Nucala (mepolizumab) as an add-on maintenance therapy for severe eosinophilic asthma in adults and adolescents ...

In addition, GSK said its Blenrep drug has been approved for priority review in China to treat sufferers of myeloma, a bone marrow cancer. The regulatory submission is supported by phase III ...