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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 Letter3d
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 ...
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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 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 ...
Pharmabiz2d
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 ...
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 Stock Declines 20% in 3 Months: Should You Buy, Sell or Hold?
Though GSK is definitely not the best large-cap drugmaker to have in one's portfolio, we believe there is potential for its ...
London South East4d
Nucala COPD submission accepted by US FDA
Submission supported by MATINEE data showing significant and clinically meaningful reduction in annualised rate of moderate/severe exacerbations compared with placebo · Nucala could be the first ...
Nasdaq3d
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 ...