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FDA
Biotech
Zydus' phase 3 win tees up filing to challenge Gilead and Ipsen
The win in primary biliary cholangitis clears the path to an FDA filing to establish the company as a challenger to Gilead, Intercept and Ipsen.
Nick Paul Taylor
Aug 29, 2025 10:59am
FDA considers new liver trial endpoint, sending MASH shares up
Aug 28, 2025 11:25am
FDA flags review of Telix's radiodiagnostic for kidney cancer
Aug 28, 2025 11:20am
RNA biotech emerges with $52M and clinical rare disease asset
Aug 25, 2025 10:13am
Krystal discontinues melanoma study after FDA's Replimune rebuff
Aug 21, 2025 10:50am
FDA aims for September approval decision for Stealth's drug
Aug 21, 2025 10:15am
