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 ...

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 ...

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

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

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 (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 ...

The headline result from the MATINEE trial of IL-5 inhibitor Nucala (mepolizumab) in adults with COPD was a statistically significant reduction in the annualised rate of moderate or severe ...

It was a busy week in the biotech sector with lots of data readouts. This apart, the key regulatory updates and pipeline news ...