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 ...
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 ...
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Biotech Stock Roundup: BIOA Down on Study Update, QURE, CRDF Gain on Study Data & More
It was a busy week in the biotech sector with lots of data readouts. This apart, the key regulatory updates and pipeline news ...
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 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 ...
pharmaphorum6y
GSK's Nucala unlikely to get COPD use after panel vote
GlaxoSmithKline’s lung disease drug Nucala is unlikely to receive US approval for chronic obstructive pulmonary disease (COPD), following judgements made by advisers. The FDA's Pulmonary-Allergy ...
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 ...
Daily1d
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 ...
pharmaphorum6y
FDA rejects GSK's Nucala in COPD, asking for more clinical data
The US regulator has rejected GlaxoSmithKline's pulmonary disease drug Nucala in a potential new chronic obstructive pulmonary disease (COPD) use. In July, Nucala (mepolizumab), which is already ...
FDA to look at data for new use of GSK's Nucala, Foresight Group extends buyback
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.
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 ...