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EU OK for Roche’s oral flu treatment Xofluza pharmatimes
January 12, 2021
The European Commission (EC) has approved Roche’s oral treatment Xofluza (baloxavir marboxil) for the treatment of influenza.
Roche’s Xofluza gets FDA approval for influenza prevention pharmaceutical-technology
November 26, 2020
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Roche’s Xofluza (baloxavir marboxil) as a treatment to prevent influenza in people aged 12 years and above following post-exposure prophylaxis.
Flu’s response to Xofluza explored europeanpharmaceuticalreview
April 22, 2019
Scientists are now investigating the Xofluza mode of action in detail and have uncovered possible mechanisms by which viral resistance to it could emerge…
FDA accepts Genentech's XOFLUZA for the treatment of Influenza biospectrumasia
March 07, 2019
The sNDA is based on results from the Phase III CAPSTONE-2 study of a single dose of XOFLUZA compared with placebo or oseltamivir 75 mg, twice daily for five days, in people 12 years of age or older who are at high risk of complications from the flu.
Will mutant strains hurt prospects for Roche's flu-fighting newcomer Xofluza? fiercepharma
February 24, 2019
Xofluza, Roche’s bid to replace sales from the now-generic Tamiflu, has yet to catch on in the U.S., and new reports of viral resistance in Japan won’t help the drug’s case.
FDA Approves Xofluza, a First-In-Class Flu Drug to Treat Symptoms drugs
November 01, 2018
FDA Approves Xofluza, a First-In-Class Flu Drug to Treat Symptoms