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FDA Panel Backs Reslizumab for Adults With Severe Asthma – Medscape


Medscape

FDA Panel Backs Reslizumab for Adults With Severe Asthma
Medscape
If approved by the FDA, it would be the third monoclonal antibody approved for asthma, after mepolizumab and omalizumab. Reslizumab binds to human interleukin-5 (IL-5). Several cytokines can affect eosinophils, but IL-5 is the main cytokine involved in …
FDA experts endorse Teva's asthma drug, but reject use in key patient groupFierceBiotech
FDA advisory panel recommends Teva asthma antibodyMedical Marketing and Media
FDA advisers recommend approval of Teva asthma drug in adultsFox News
Reuters –Business Wire (press release)
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CHMP Backs Mepolizumab for Severe Eosinophilic Asthma – Medscape


Medscape

CHMP Backs Mepolizumab for Severe Eosinophilic Asthma
Medscape
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of mepolizumab (Nucala, GlaxoSmithKline) for add-on maintenance treatment in adults with severe refractory eosinophilic asthma, …
EU regulator backs approval for GSK injectable asthma drugReuters
GlaxoSmithKline's asthma injection heads for EU approvalFierceBiotech
Glaxo asthma drug clears key hurdle in EuropeMarketWatch
Bidness ETC
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EU regulator backs approval for GSK injectable asthma drug – Yahoo News


Yahoo News

EU regulator backs approval for GSK injectable asthma drug
Yahoo News
The treatment could help boost GSK's respiratory drugs business as demand weakens for its asthma drug, Advair. A significant minority of asthma patients do not respond to regular inhalers such as Advair, Dulera and Flovent, creating what analysts …
Glaxo asthma drug clears key hurdle in EuropeMarketWatch
CHMP Backs Mepolizumab for Severe Eosinophilic AsthmaMedscape
GlaxoSmithKline's asthma injection heads for EU approvalFierceBiotech
Bidness ETC
all 32 news articles »

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EU regulator backs approval for GSK injectable asthma drug – Reuters


Reuters

EU regulator backs approval for GSK injectable asthma drug
Reuters
GlaxoSmithKline Plc said the European health regulator had recommended an approval for its injectable drug to treat asthma patients who don't respond well to traditional inhalers. The European Commission is expected to decide on a final approval for …
Glaxo asthma drug clears key hurdle in EuropeMarketWatch
GlaxoSmithKline's asthma injection heads for EU approvalFierceBiotech
Europe's CHMP give thumbs up to Glaxo's Nucala for severe asthmaSeeking Alpha

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FDA Panel Backs Mepolizumab for Severe Eosinophilic Asthma – Medscape


Medscape

FDA Panel Backs Mepolizumab for Severe Eosinophilic Asthma
Medscape
A typical characteristic of mild asthma is airway inflammation due to eosinophils, and this inflammation is closely associated with the risk for severe asthma exacerbations. Several products are approved for long-term maintenance treatment of asthma …
FDA panel backs approval of GSK asthma drug in adultsReuters
Asthma Drug Targeting IL-5 Wins Partial Backing From FDA AdvisersMedPage Today
UPDATE: Glaxo's (GSK) Severe Asthma Drug Mepolizumab Found Effective in …StreetInsider.com
Healio
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UPDATE 1-FDA panel backs approval of GSK asthma drug in adults – Reuters


MedPage Today

UPDATE 1-FDA panel backs approval of GSK asthma drug in adults
Reuters
If approved, the drug would be marketed under the trade name Nucala and be the first new biologic treatment for severe asthma in more than a decade. Asthma affects more than 22 million people in the United States. Severe asthma accounts for 5 to 10 …
UPDATE: Glaxo's (GSK) Severe Asthma Drug Mepolizumab Found Effective in …StreetInsider.com
Asthma Drug Targeting IL-5 Wins Partial Backing From FDA AdvisersMedPage Today
FDA committee recommends approval of Nucala for adults with severe asthmaHealio
Reuters India
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FDA panel backs approval of GSK asthma drug in adults – Reuters


Reuters

FDA panel backs approval of GSK asthma drug in adults
Reuters
An advisory committee to the U.S. Food and Drug Administration recommended approval on Thursday of GlaxoSmithKline Plc's drug mepolizumab for severe asthma in patients aged 18 and older. The panel voted 10 to 4 against approving it in children aged …
UPDATE: Glaxo's (GSK) Severe Asthma Drug Mepolizumab Found Effective in …StreetInsider.com
FDA committee recommends approval of Nucala for adults with severe asthmaHealio

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UPDATE 2-FDA panel backs Glaxo asthma drug for adults, not adolescents – Reuters


Channel News Asia

UPDATE 2-FDA panel backs Glaxo asthma drug for adults, not adolescents
Reuters
The panel voted 16-4 that Breo Ellipta should be approved for once daily treatment of asthma in adults 18 years and older. It voted 19-1 that the data did not support approval for use in children aged 12 to 17. The FDA is not obliged to follow the …
U.S. Panel Backs Glaxo's Breo for Adults With Asthma, Not KidsBloomberg
GSK's Breo for asthma? FDA panel says yes–but only in adultsFiercePharma
FDA panel backs Glaxo asthma drug for adults, not adolescentsBusiness Insider
WallStreet.org –Fox Business
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