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The European Commission (EC) has approved Roche’s oral treatment Xofluza (baloxavir marboxil) for the treatment of influenza.
January 12, 2021
by pharmatimes
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.
December 9, 2020
by americanpharmaceuticalreview
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.
November 26, 2020
by pharmaceutical-technology
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
November 17, 2020
by europeanpharmaceuticalreview
Scientists are now investigating the Xofluza mode of action in detail and have uncovered possible mechanisms by which viral resistance to it could emerge…
April 22, 2019
by europeanpharmaceuticalreview
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.
March 7, 2019
by biospectrumasia
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.
February 24, 2019
by fiercepharma
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......
December 20, 2018
by pharmaphorum
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...
November 1, 2018
by pharmatimes
FDA Approves Xofluza, a First-In-Class Flu Drug to Treat Symptoms
November 1, 2018
by drugs
When Shionogi got Japanese approval for its novel flu drug Xofluza (baloxavir marboxil) in February, it didn’t expect a U.S. decision in 2018. Now, an FDA priority review has made it possible for its partner Roche to get a go-ahead before New Year's.
June 27, 2018
by fiercepharma
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