Keeping Track: US FDA Oncology Approvals For Ferring’s Gene Therapy Adstiladrin And Mirati’s Targeted Therapy Krazati
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Side Step-Wise Development: Sponsors Aren’t Using FDA’s Preferred Approach To Biosimilars
Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.
Side Step-Wise Development: Sponsors Aren’t Using FDA’s Preferred Approach To Biosimilars
Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.
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."