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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 ...
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 ...
pulmonologyadvisor2d
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.
pharmaphorum4d
GSK says Nucala hits the target in new COPD trial
GSK's severe asthma therapy Nucala could find a new lease of life as a treatment for chronic obstructive pulmonary disease (COPD) after showing a clear benefit in a phase 3 trial. The headline ...
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 ...
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 ...
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 ...
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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 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 ...
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 ...