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15 September, 2026 |
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The FDA finally launched its long-awaited investigational new drug pilot program and began accepting applications Tuesday. Top agency officials said they included public input into who should be able to apply. Max Bayer has the details here. |
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Karen Weintraub |
Deputy Editor, Endpoints News
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by Max Bayer
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The FDA’s long-awaited expedited investigational new drug pilot program began accepting applications Tuesday, with top agency officials incorporating public feedback into who should qualify. Karim... | |
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by Max Gelman
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The French biotech Axoltis Pharma reported a Phase 2 failure in ALS on Tuesday morning, but suggested it found a small signal to move the... | |
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by Lei Lei Wu
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Sionna Therapeutics announcedit was laying off 46% of its staff as it seeks a way forward following an unexpected trial failure in cystic fibrosis... | |
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by Nicole DeFeudis
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As the FDA ramps up its effort to accelerate the development of psychedelic therapies, mental health experts on Monday urged the agency to consider certain... | |
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