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

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

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 (mepolizumab) in chronic obstructive pulmonary disease (COPD) treatment for ...

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 ...

London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study ...

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’s Nucala (mepolizumab) has gained a new FDA approval for the rare autoimmune disease eosinophilic granulomatosis with polyangiitis (EGPA). Nucala, an interleukin-5 (IL-5 ...

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

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 ...

GSK said the US Food and Drug Administration has agreed to look at data from its MATINEE study to support the regulatory review process to obtain a new use of its Nucala drug as an add-on maintenance ...