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1. Updated: CDER chief Høeg, skeptic of vaccines and antidepressants, is fired in high-level FDA shakeup
2. FDA's unreleased Covid vaccine deaths report is published by lawmaker
3. Supreme Court preserves mail access for abortion pill
4. Amgen stands by Tavneos, despite reports of 20 deaths in Japan
5. TrumpRx adds more than 600 generic meds, building on one success in US pricing
6. Post-Hoc Live: Marty Makary's FDA downfall and legacy
Max Bayer
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After former FDA Commissioner Marty Makary resigned last week, a high-level shakeup of the key regulator led to a slew of exits and new roles. Acting CDER director Tracy Beth Høeg said she was fired, acting CBER chief Katherine Szarama and Chief of Staff Jim Traficant were replaced, though they're staying at the agency, and reports said that Chief AI Officer Jeremy Walsh resigned. The search for a permanent commissioner replacement is now on, which the Trump administration is reportedly hoping to conduct quickly.

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Max Bayer
Pharma Reporter, Endpoints News
Tracy Beth Høeg (Mike Stewart/AP Images)
1
by Max Bayer, Drew Armstrong

The leader of the FDA's drug di­vi­sion, Tra­cy Beth Høeg, is ex­pect­ed to de­part, as part of a broad shake­up at the top of the...

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2
by Drew Armstrong

An analy­sis launched by for­mer FDA lead­ers to look in­to claims of pe­di­atric deaths re­lat­ed to Covid-19 vac­cines was pub­lished by a Re­pub­li­can law­mak­er, months...

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3
by Nicole DeFeudis

The Supreme Court will con­tin­ue to al­low the abor­tion pill mifepri­s­tone to be dis­trib­uted by mail, at least for now.

The Thurs­day rul­ingmain­tains mifepri­s­tone's...

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4
by Andrew Dunn

The FDA wants it off the mar­ket. Eu­ro­pean reg­u­la­tors are in­ves­ti­gat­ing da­ta-in­tegri­ty con­cerns. And now, a phar­ma com­pa­ny sell­ing the drug in Japan is warn­ing...

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President Donald Trump with Mark Cuban and CMS Administrator Mehmet Oz on May 18, 2026 (Julia Demaree Nikhinson/AP Images)
5
by Max Bayer

The Trump ad­min­is­tra­tion is sig­nif­i­cant­ly build­ing the port­fo­lio of drugs avail­able through its di­rect-to-con­sumer plat­form TrumpRx, adding more than 600 gener­ic med­i­cines.

Pres­i­dent Don­ald Trump...

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6
by Drew Armstrong

Mar­ty Makary re­signed as FDA com­mis­sion­er on Tues­dayaf­ter a tur­bu­lent tenure at the head of the agency. Makary was sched­uled to sit down with...

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