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 ...
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 ...
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 ...
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 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 ...
Nasdaq4d
GSK: FDA Accepts For Review Submission For New Indication Of Nucala In COPD
COPD affects more than 390 million people globally and over 14 million people in the US. GSK noted that recurrent exacerbations add to pressures on healthcare systems, and the COPD -related ...