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Sinovant Sciences and Nabriva Therapeutics Announce Positive Topline Results from Phase 3 Trial of Lefamulin in Chinese Adults with Community Acquired Bacterial Pneumonia (CABP)
prnasia
May 26, 2021
Sinovant Sciences today announced positive topline results from Sinovant's Phase 3 bridging study of lefamulin in Chinese adults with community acquired bacterial pneumonia (CABP).
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Nabriva Receives Positive Opinion for XENLETA for Community-Acquired Pneumonia
americanpharmaceuticalreview
June 09, 2020
Nabriva Therapeutics announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of XENLETA (lefamulin) for the treatment of community-acquired pneumonia..
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Nabriva Receives FDA Acknowledgement of NDA Resubmission for CONTEPO
americanpharmaceuticalreview
January 14, 2020
Nabriva Therapeutics announced the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its New Drug Application (NDA) resubmission for marketing approval of CONTEPO™ (fosfomycin) for injection for ...
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Nabriva Therapeutics Resubmits NDA for Intravenous CONTEPO
americanpharmaceuticalreview
December 23, 2019
Nabriva Therapeutics has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CONTEPO™ (fosfomycin) for ...
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FDA approves Nabriva’s antibiotic for pneumonia
expresspharma
August 21, 2019
The US Food and Drug Administration said that it had approved Nabriva Therapeutics’ antibiotic Xenleta for treating patients with community-acquired pneumonia.
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Nabriva’s bacterial pneumonia drug gets US regulatory approval
August 21, 2019
Nabriva Therapeutics has received US regulatory approval for Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia (CABP).
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Nabriva hit with FDA rejection of Contempo for complicated urinary tract infections
pharmatimes
May 10, 2019
Nabriva hit with FDA rejection of Contempo for complicated urinary tract infections.
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After Zavante deal, Nabriva is poised to launch two first-in-class antibiotics
GlobalData Healthcare
August 20, 2018
On July 24, Nabriva Therapeutics announced the acquisition of Zavante Therapeutics, a biotechnology company developing treatments for the infections that threaten hospitalized patients.
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Nabriva closes in on bringing new class of antibiotic to market
pharmafile
May 25, 2018
Nabriva Therapeutics, a biotech based in Dublin, Ireland, has announced positive Phase 3 data for its antibiotic, lefamulin, which could result in a newly approved antibiotic for doctors to utilise – a type of approval that are few and far between.
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Nabriva Announces Positive Trial Results
contractpharma
May 22, 2018
Nabriva Therapeutics announced positive topline results from its Lefamulin Evaluation Against Pneumonia (LEAP 2) clinical trial, the second of two global, pivotal Phase 3 clinical trials of lefamulin.