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FDA`

This page shows the latest FDA` news and features for those working in and with pharma, biotech and healthcare.

Roche scores another FDA approval for Xofluza

Roche scores another FDA approval for Xofluza

Expands use to patients at high risk of flu-related complications. Roche’s Xofluza (baloxavir marboxil) has received FDA approval for use in people who have a high risk of developing ... Roche received its first FDA approval for the drug  last year,

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  • European biotech: a new generation of leaders emerges European biotech: a new generation of leaders emerges

    It had promising new trial data unveiled in May this year for its lead candidate the anti-CD19 antibody tafasitamab (MOR208), and an FDA filing expected by the end of this ... Another of its partners, Horizon Therapeutics recently submitted to the FDA

  • Encouraging signs in biomarker R&D Encouraging signs in biomarker R&D

    He also cited an FDA-approved TMB test developed by Foundation Medicine and Memorial Sloan Kettering Cancer Center as an example. ... is quite a difference between FDA and EMA in policy here, as the latter requires larger RCT.”.

  • The evolution of real-world studies The evolution of real-world studies

    Ned Sharpless, Acting FDA Commissioner. Similar discussions are taking place across the Atlantic. ... Elsewhere, the EMA has compared the FDA’s real-world Sentinel safety system favourably to.

  • Real-world studies Real-world studies

    Advances like that which we saw in November last year, when the FDA unveiled its own MyStudies app for the collection of real-world data, will continue to drive the use

  • The Cystic Fibrosis Buyers’ Club The Cystic Fibrosis Buyers’ Club

    The movement proved to be hugely influential, and by the early 1990s its activism had spurred the FDA to introduce ‘accelerated approval’ that allowed experimental yet promising drugs to be made ... The FDA hadn’t been willing to override its

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