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 ...
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 ...
Daily2d
USFDA accepts GSK submission for use of Nucala in COPD
London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study ...
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 ...
London South East4d
Nucala COPD submission accepted by US FDA
Nucala has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation. About the mepolizumab development programme for COPD The mepolizumab program ...
Nasdaq3d
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 (mepolizumab) in chronic obstructive pulmonary disease (COPD ...
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 ...
Nasdaq4d
GSK: FDA Accepts For Review Submission For New Indication Of Nucala In COPD
The submission seeks an indication for the use of Nucala as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype. The Prescription Drug User Fee Act (PDUFA ...