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Uncategorized1 day ago
Biotech Looks to Replimune RP1 Decision as ‘First Indicator’ of FDA Direction
Biotech Looks to Replimune RP1 Decision as ‘First Indicator’ of FDA Direction
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Uncategorized1 day ago
FDA Reversals in Rare Disease Space Highlight Confusion Around External Controls
While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent....
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Uncategorized1 day ago
StockWatch: Price War Dampens Lilly Surge After Oral GLP-1 Wins FDA Nod
Eli Lilly (NYSE: LLY) won the approval it sought when the FDA authorized the company’s oral obesity drug Foundayo (orforglipron), but the pharma giant’s post-approval stock...