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BRIEF-GSK submits application for Japanese approval of asthma drug
Reuters May 22 GlaxoSmithKline Plc : * Submits Japan regulatory application for mepolizumab in severe eosinophilic asthma. * Mepolizumab is an anti il-5 monoclonal antibody delivered in a 100mg fixed dose via a subcutaneous injection every four weeks. |
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GlaxoSmithKline (GSK), Theravance (THRX) Announces US FDA Approval of …
StreetInsider.com GlaxoSmithKline (NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) announced that the US Food and Drug Administration (FDA) has approved BREO ELLIPTA (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 … Glaxo Wins U.S. Approval to Sell Breo Only to Adults With Asthma FDA approves Glaxo's inhaler drug Breo Ellipta for new use in treating adults … |
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Uncover California |
FDA Panel Recommends Asthma Treatment Approval for Adults Only
Pharmacy Times (registration) "We recognize the advisory committee's thoroughness in reviewing the data related to Breo Ellipta for asthma,” said Darrell Baker, senior vice president and head of GSK's Global Respiratory Franchise, in a press release. “We will continue to work … GSK And Theravance: Implications Of The Advisory Panel Decision Breo Ellipta receives Mixed Views from FDA Panel |
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GSK Files For Approval Of Mepolizumab In US, Europe For Eosinophilic Asthma
Nasdaq The submissions include a Biologics Licence Application to the US Food and Drug Administration as an add-on maintenance treatment for severe eosinophilic asthma in patients aged 12 years and older with a history of exacerbations. It also comprises a … |
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Bidness Etc |
GlaxoSmithKline grabs FDA approval for its latest asthma treatment
FierceBiotech "The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio," Senior Vice President Darrell Baker said in a statement. "It is the first asthma treatment from our new portfolio to have gained approval in … GSK's Asthma Treatment Gets FDA Approval FDA OKs New Maintenance Asthma Treatment Arnuity Ellipta FDA approves GSK asthma medicine |
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Bidness Etc |
GSK's Asthma Treatment Gets FDA Approval
Bidness Etc Yesterday, GlaxoSmithKline plc (GSK) announced that the Food and Drug Administration (FDA) has given marketing approval for its drug Arnuity Ellipta, developed as an asthma treatment in patients aged 12 and older. Asthma is a lingering lung disease … FDA OKs New Maintenance Asthma Treatment Arnuity Ellipta FDA approves GSK asthma medicine FDA approves GSK's Arnuity Ellipta for treating asthma |
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GSK receives FDA approval for Arnuity™ Ellipta® (fluticasone furoate) in the …
MarketWatch 20, 2014 /PRNewswire/ — GlaxoSmithKline plc today announced that the FDA has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic … |
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EU Panel Recommends Approval for 6 COPD, Asthma Drugs
Medscape The 2 drugs receiving a positive CHMP opinion for treatment of adults with asthma and COPD are the combination of the inhaled corticosteroid budesonide and the long-acting ?2 agonist formoterol, under the brand names of DuoResp Spiromax and BiResp … GSK lung drug Anoro recommended for European approval EU Agency backs respiratory drugs for approval GSK share price: Pharma giant closes in on another COPD drug approval in … |
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GSK, Theravance Announce Relvar Ellipta Approval In Japan For Asthma …
RTT News GlaxoSmithKline plc(GSK: Quote,GSK.L), and Theravance, Inc.(THRX: Quote), Friday said that Relvar Ellipta for the treatment of bronchial asthma got approval from the Japanese Ministry of Health, Labour and Welfare. The company said Relvar Ellipta is … Japan approves lung drugs from GSK/Theravance and SkyePharma Glaxo's Relvar Lung Treatment Recommended by EU Regulator GlaxoSmithKline Treatments Given Positive Opinion In Europe, Approved in Japan |
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Approval given for SkyePharma's asthma treatment
Stock Market Wire StockMarketWire.com – SkyePharma (LSE SKP) has announced that the UK regulatory authority, the Medicines and Healthcare product Regulatory Agency (MHRA), has granted marketing authorisation for flutiform®, a combination product for the treatment of … SKYEPHARMA PLC : Half Yearly Report |
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