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

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 ...

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 ...

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 ...

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

Though GSK is definitely not the best large-cap drugmaker to have in one's portfolio, we believe there is potential for its ...

· Submission supported by MATINEE data showing significant and clinically meaningful reduction in annualised rate of moderate/severe exacerbations compared with placebo · Nucala could be the ...

GSK noted that recurrent exacerbations add to pressures on healthcare systems, and the COPD -related medical costs and others cost the US healthcare system around $7 billion a year. Nucala is ...

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 ...