pulmonologyadvisor14h
Mepolizumab Under Review for Eosinophilic COPD
The FDA has accepted for review the BLA for mepolizumab as an add-on maintenance treatment for eosinophilic COPD.
GSK: FDA Accepts For Review Submission For New Indication Of Nucala In COPD
British drug maker GSK plc (GSK, GSK.L) announced Monday that the U.S. Food and Drug Administration has accepted for review, data ...
FDA to review GSK’s Nucala for COPD
The US Food and Drug Administration (FDA) has accepted a submission from GSK to review a new indication of Nucala ...
pharmaphorum7y
GSK seeks COPD approval for mepolizumab
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 ...
GSK says US agrees to look at data for new use of COPD drug
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 ...
FDA Accepts GSK's Filing for Expanded Use of Nucala in COPD
GSK plc GSK announced that the FDA has accepted its regulatory filing, seeking the approval of a new indication for Nucala ...
GSK announces U.S. FDA accepted its submission for use of Nucala in COPD
GSK (GSK) announced the US Food and Drug Administration, FDA, has accepted for review, data from the MATINEE study to support the regulatory ...
The Pharma Letter2d
FDA accepts GSK’s re-submission for Nucala
After previously rejecting an application for this indication, the US Food and Drug Administration (FDA) has now accepted for ...
GSK's Nucala and Blenrep receive regulatory boost in US and China
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 ...