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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.
FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention americanpharmaceuticalreview
December 09, 2020
The U.S. Food and Drug Administration (FDA) expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu.
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.
CHMP recommends five medicines for approval in latest meeting europeanpharmaceuticalreview
November 17, 2020
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
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.
Roche claims US approval for novel flu treatment pharmaphorum
December 20, 2018
The US FDA has given a green light to a new influenza treatment from Shionogi and Roche that has the first new mechanism of action in more than two decades......
US approves first-in-class flu drug pharmatimes
November 01, 2018
The US Food and Drug Administration has approved Roche/Shionogi & Co’s Xofluza for the treatment of acute uncomplicated flu, opening the door to the first new antiviral with a...
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

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