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

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

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

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

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

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

Earlier this year, researchers of Brigham and Women’s Hospital Harvard Medical School looked at clinical trials to show how six biologics, in particular, improve lung function; cut down on steroid use ...

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

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 ...

GlaxoSmithKline has asked the US regulator to expand the licence of its injected lung drug mepolizumab, to include chronic obstructive pulmonary disease (COPD). Under the brand name Nucala ...

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 ...