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

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

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 ...

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 ...

GSK's severe asthma therapy Nucala could find a new lease of life as a treatment for chronic obstructive pulmonary disease (COPD) after showing a clear benefit in a phase 3 trial. The headline ...

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 ...