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Wednesday
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14 October, 2026 |
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The FDA has announced a new rare disease initiative on Wednesday, meant to better engage drug developers and patients along the entire regulatory process. The Rare Disease Framework Initiative is expected to be a broader and a more encompassing program than the plausible mechanism pathway unveiled by previous agency leaders at the tail end of 2025. A late October meeting is planned to solicit feedback from industry and patient stakeholders, facilitated by the Reagan-Udall Foundation. |
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Max Bayer |
Senior Reporter, Endpoints News
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by Max Bayer
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The acting general counsel at HHS, Bob Foster, is no longer at the agency. When Endpoints Newscontacted Foster through his government email, it received... | |
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by Max Bayer
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Top pharmaceutical trade groups say the FDA will have a dedicated pool of money to replenish its stable of reviewers as part of the new... | |
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by Max Bayer
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The pharma industry is yet again taking the government to court over its latest effort to control US drug prices. Last week, the Trump administration... | |
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by Max Bayer
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There is some good news in the world of antibiotics. Novartis quietly snagged supplemental FDA approval for its drug Lamprene over the summer, transitioning a decades-old... | |
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by Kyle LaHucik
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Ultragenyx Pharmaceutical is selling a priority review voucher to an undisclosed buyer for $210 million, marking one of the richest sales of the speedy-approval... | |
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by Max Bayer
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Japanese pharma Asahi Kasei Therapeutics has snagged FDA approval for a herpes treatment that it acquired early this year in an almost $1 billion deal... | |
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Worldwide made. Thanks for reading.
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