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PDUFA VIII commitments include Makary’s pro-US plans Read in browser
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top stories
1. Trump to pick Heidi Overton to lead the FDA following a run of volatile leadership
2. Trump is taking credit for lower list prices. But a Biden-era law did a lot of the heavy lifting
3. PDUFA VIII commitments: 'America First' provisions, faster reviews and more
4. Drugmakers voice support of US probe into Germany’s drug pricing plans
5. Federal appeals court revives part of Teva's IRA case as Austedo price cuts loom
6. 'Incorrect and misleading' data prompted regulators' decision to pull Tavneos in Europe
Zachary Brennan
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Trump's second pick for FDA commissioner, Heidi Overton, may be more controversial than his first, Marty Makary, who resigned after a series of controversies. Overton, a former White House domestic policy official, could face heated questions during her Senate confirmation hearing as she's made clear she fully supports HHS Secretary Robert F. Kennedy Jr.'s push to reduce the number of shots for children. And when it comes to the abortion drug mifepristone, which the FDA has been tasked with conducting another safety review on, Overton has written that she thinks the current state of "chemical abortion poses serious risks." If confirmed, Overton's first test will be naming CBER and CDER directors. Will she promote the acting directors or go in a different (potentially more political) direction? Stay tuned.

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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
FDA commissioner nominee Heidi Overton with President Donald Trump (Francis Chung/Politico via AP Images)
1
by Max Bayer

Pres­i­dent Don­ald Trump is ex­pect­ed to nom­i­nate Hei­di Over­ton to be the next FDA com­mis­sion­er, ac­cord­ing to a source fa­mil­iar with the de­ci­sion, set­ting a...

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President Donald Trump speaking about TrumpRx with CMS Administrator Mehmet Oz at the White House, Feb. 5, 2026 (Alex Brandon/AP Images)
2
by Zachary Brennan

List prices for brand-name drugs have de­clined sig­nif­i­cant­ly in 2026. But the rea­sons be­hind it may have more to do with a Biden-era law than...

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3
by Zachary Brennan

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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4
by Anna Brown

Sev­en large drug­mak­ers and lob­by­ing groups PhRMA and BIO have called up­on the Ger­man gov­ern­ment to re­vise some of its new drug pric­ing poli­cies as...

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5
by Nicole DeFeudis

Af­ter a low­er court re­ject­ed Teva's case last fall, a fed­er­al ap­peals court has re­vived part of the drug­mak­er’s law­suit against Medicare ne­go­ti­a­tions.

The DC...

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6
by Nicole DeFeudis

Eu­ro­pean reg­u­la­tors on Thurs­day ex­plained last week's de­ci­sion to pull Am­gen's rare dis­ease drug Tavneos from the mar­ket there, de­tail­ing their skep­ti­cism about the da­ta...

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