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17 June, 2026 |
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If three's a trend, the potential reversal of four recent CRLs certainly signals a new approach from the FDA around rare disease drugs. Zach Brennan has the story about what that could mean for other drugmakers looking to change their fate. |
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Lydia Ramsey Pflanzer |
Deputy Editor, Endpoints News
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by Zachary Brennan
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Did you receive a complete response letter in the past year? Now may be the time for a resubmission. In the wake of FDA Commissioner... | |
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by Shelby Livingston
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The FDA has issued a new batch of warning letters to 25 telehealth companies, accusing them of making false and misleading claims in their marketing... | |
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by Ayisha Sharma
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The waiting list at a UK online pharmacy for Novo Nordisk’s Wegovy pill now stands at 30,000 people a week after approval, in a sign... | |
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by Elizabeth Cairns
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Novo Nordisk got robbed and is in the unenviable position of being extorted by the thieves. At stake, according to a group that has claimed... | |
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by Max Gelman
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Regulatory flexibility appears to be back on the FDA’s menu following the departures of Marty Makary and Vinay Prasad. At the center of the... | |
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AbCellera CEO Carl Hansen (L) and Jazz Pharmaceuticals' Joshua Allen |
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by Kyle LaHucik
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For much of its first decade, Canadian antibody developer AbCellera signed partnership after partnership, securing 40 biopharma alliances that led to more than a dozen... | |
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