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 ...

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

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 ...

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

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 ...

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 ...

The following is a summary of “Effect of Mepolizumab in airway’s remodelling in patients with late-onset severe asthma with ...

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 ...