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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 ...
pulmonologyadvisor17h
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.
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 ...
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 ...
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 ...
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: 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 ...
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 ...
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 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 ...
Too Old to Operate17d
Impact of Mepolizumab on Airway Changes in Late-Onset Severe Asthma
The following is a summary of “Effect of Mepolizumab in airway’s remodelling in patients with late-onset severe asthma with an eosinophilic phenotype,” published in the November 2024 issue of Allergy ...