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13 August, 2026 |
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Details of the FDA's next prescription drug user fee agreement (2028 to 2032) surfaced Thursday, with an interesting twist. The commitment letter doesn't include provisions backed by former FDA Commissioner Marty Makary to incentivize US drug development with lower user fees. But those lower user fees for US-based companies will be included in the wider legislative package readying for congressional passage before September 2027, the FDA and industry sources said. Stay tuned for what else might make its way into that package. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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by Nicole DeFeudis
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European regulators on Thursday detailed their skepticism of data behind Amgen's rare disease drug Tavneos, explaining a decision last week to pull the drug from... | |
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by Zachary Brennan
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The FDA's next five-year reauthorization of the prescription drug user fee program will feature new incentives for domestic pharma companies, newly sped up reviews for... | |
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by Kyle LaHucik
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About 26 months after failing two Phase 3 trials, an epilepsy treatment candidate is getting plucked off biopharma's shelves and will be given a new... | |
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by Ayisha Sharma
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Taiho Oncology and Cullinan Therapeutics said Wednesday that their next-gen EGFR inhibitor has cleared a registrational trial in the front-line setting of a genetically-defined type... | |
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by Elizabeth Cairns
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The bankrupt gene editing biotech Sangamo is set to sell chunks of its business to PTC Therapeutics and Eli Lilly for up to $264 million... | |
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Worldwide made. Thanks for reading.
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