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Judge blocks enforcement of WuXi AppTec's designation as Chinese military company Read in browser
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top stories
1. GDUFA IV commitments: New onshoring incentives and meeting types for generic drugs
2. Trump calls for spacing out MMR vaccine into three shots, suggests it causes autism
3. Judge blocks enforcement of WuXi AppTec's designation as Chinese military company
4. FDA to hold adcomm for Grail cancer test that failed in large, randomized trial
5. Exclusive: FDA outlines expedited IND pilot plans, seeking to pick up to 10 programs by year's end
6. FDA approves Moderna flu vaccine after spat with past agency leaders
7. Manufacturing problems cited in FDA rejection of ITM's radiopharma drug
8. BINSA is back: Senate bill emerges, adding pressure on Treasury to screen China biotech deals
9. Senate confirms Erica Schwartz as CDC director
Zachary Brennan
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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

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

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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3
by Nicole DeFeudis

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

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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5
by Max Bayer

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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6
by Max Bayer

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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