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Wednesday
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12 August, 2026 |
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Big thank you to all of our 120,000+ subscribers, and be sure to forward your FDA+ newsletter to anyone who you think might be interested. Couple of tidbits around FDA world this week: 1) FDA today finalized 2023 guidance on formal meetings between the agency and drug companies. Changes from the draft to the final guidance include additional scenarios for Type D meetings and the addition of information on meeting formats that FDA may grant. 2) The biopharma lobbying group PhRMA is backing a government investigation into whether the US can take action against Germany’s "persistent underpayment for innovative pharmaceutical products." 3) Operation TrialBlazer: Acting CBER chief wrote about the incoming pilot last week on FDA's blog. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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by Zachary Brennan
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From 2028 to 2032, generic drug applicants will continue to see many of the same FDA review timelines as they did over the last five... | |
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President Donald Trump with HHS Secretary Robert F. Kennedy Jr. at the Oval Office on Aug. 10, 2026 (Jacquelyn Martin/AP Images) |
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by Max Bayer
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President Donald Trump further asserted control over the nation’s childhood vaccine schedule, calling for the measles, mumps and rubella (MMR) vaccine to split into three... | |
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by Nicole DeFeudis
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A federal judge has suspended the Pentagon's designation of WuXi AppTec as a company with alleged ties to the Chinese military. Judge James Boasberg wrote... | |
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The Grail booth at the ASCO 2026 meeting. (Karen Weintraub / Endpoints News) |
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by Zachary Brennan
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The FDA will host an advisory committee meeting in September to review Grail's controversial cancer test that failed to meet the primary endpoint of a... | |
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by Max Bayer
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As the debate rolls on over how the US can better compete with China on drug development, the FDA is detailing plans for an expedited... | |
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by Max Bayer
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Moderna may be publicly pivoting toward its cancer therapies, but it's still notching new vaccine approvals along the way. The latest regulatory approvalcame
well... | |
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