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 ...

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

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

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 ...

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 ...

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 ...

London open The FTSE 100 is expected to open eight points higher on Monday, having closed down 0.49% on Friday at 8,308.61.

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

bepirovirsen (Chronic hepatitis B virus infection), linerixibat (Cholestatic pruritus in primary biliary cholangitis), and mepolizumab nucala for chronic obstructive pulmonary disease. The GSK share ...

GSK's experimental IL-5 inhibitor depemokimab ... The antibody is a follow-up to the company's once-monthly IL-5 inhibitor Nucala (mepolizumab), which has been on the market since 2015.