Ferring’s Fecal Transplant Gets Through AdComm, Aided By Preference For Standardized Product
US FDA's Vaccines and Related Biological Products Advisory Committee endorses Rebyota for recurrent C. difficile infection; most panelists prefer a product whose manufacturing will be regulated, even one with lingering concerns about efficacy or safety, over the current landscape.
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Ferring Reflects On Fruitful 2022 As Filing Costs Hit Profits
While reproductive medicine and maternal health remains the mainstay for the Swiss group, Ferring president Per Falk says the approvals of the microbiome treatment Rebyota and bladder cancer gene therapy Adstiladrin represent "important avenues for exploration and growth."
CDI Market Snapshot: Microbiome Therapies Begin Descent On Landscape
The recent US approval of Ferring’s microbiome-targeting Rebyota is set to change the treatment landscape for recurrent Clostridioides difficile infection and could be the proving ground for this class of agents. Rebyota is the first microbiome-targeting treatment to reach the market, but several promising candidates for the same indication are waiting in the wings.
Keeping Track: Rebyota, Rezlidhia Rev Up US FDA Approvals; New Sponsors Sought For Poziotinib, Brexafemme
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.