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.
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 ...
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 ...
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 ...
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 ...
Pharmabiz1d
US FDA accepts GSK’s submission for the use of Nucala to treat patients with chronic obstructive pulmonary disease
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 ...
pharmaphorum4y
GSK eyes nasal polyps use for Nucala after trial success
GlaxoSmithKline is eyeing another indication for its Nucala (mepolizumab) biologic drug after a phase 3 trial in inflammation caused by nasal polyps hit its targets, bringing it into competition ...
pharmaphorum6y
GSK's Nucala unlikely to get COPD use after panel vote
Committee members voted on the basis of data presented and concluded that the risk-benefit profile for Nucala (mepolizumab) was not sufficient to support approval - three voted for; 16 against.
GSK’s Nucala succeeds in late-stage study for lung disorder, COPD
GSK (NYSE:GSK) announced Friday that its asthma therapy Nucala (mepolizumab) reached the main goal in a Phase 3 trial for ...
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 ...
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 ...
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 ...