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22 October, 2025
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top stories
1. Makary expands scope of new FDA voucher program with first batch of recipients
2. FDA staffing data show historic numbers of departures in fiscal 2025
3. Pfizer CEO says US must compete better against China, not block it
4. White House makes new ‘most favored nation’ deal, shares updates on FDA vouchers, GLP-1 negotiations
5. Mark Cuban's online pharmacy to partner with White House's TrumpRx
6. Ex-FDA leaders take helm of new consultancy, discuss the state of the agency
7. Former FDA deputy Bumpus to lead Charles River's new scientific advisory board
8. CHMP rejects Sanofi’s Rezurock over clinical data issues, but recommends BTK inhibitor Wayrilz
9. Post-Hoc: As China moves beyond ‘me-too,’ do Western regulators need to reconsider?
Zachary Brennan
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FDA Commissioner Marty Makary, CBER Director Vinay Prasad and senior advisor Sanjula Jain-Nagpal took to the airwaves on YouTube earlier this week, for the first time since Prasad departed and then returned to the FDA. The trio offered up some sharp critiques of anti-FDA Wall Street Journal editorials that referred to Prasad as "the grim reaper." Makary said the WSJ opinion desk has been the most critical of any news outlet or editorial team, adding, "I don't think they believe in an FDA." Prasad also revealed that more details behind the new "plausible mechanism" drug approval pathway for rare diseases are coming in the next two weeks in the New England Journal of Medicine.

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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
FDA Commissioner Marty Makary speaks alongside President Donald Trump during an announcement about in vitro fertilization in the Oval Office at the White House Oct. 16, 2025. (Francis Chung/POLITICO via AP Images)
1
by Max Bayer, Zachary Brennan

FDA Com­mis­sion­er Mar­ty Makary un­veiled the first nine com­pa­nies to win his new Na­tion­al Pri­or­i­ty Vouch­ers, a big­ger co­hort than orig­i­nal­ly planned as part of the agency’s ef­fort to sig­nif­i­cant­ly cut some drug re­view times.

The vouch­er pro­gram aims to re­view se­lect­ed drugs in as lit­tle as one month af­ter sub­mis­sion, in­stead of the typ­i­cal 10 to 12-month time­line. When it was first an­nounced in June, the FDA said up to five com­pa­nies would par­tic­i­pate in the first year, ac­cord­ing to a web­page screen­shot from Ju­ly.

That lan­guage has since been re­moved from the FDA’s site. Makary has vowed to re­lease even more vouch­ers in the com­ing weeks, align­ing with Pres­i­dent Don­ald Trump’s pri­or­i­ties for low­er­ing drug prices and in­creas­ing US man­u­fac­tur­ing.

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2
by Zachary Brennan

The FDA's drug and bi­o­log­ics cen­ters saw near­ly 1,000 net de­par­tures in the last quar­ter of fis­cal 2025, the lat­est agency hir­ing da­ta show, re­veal­ing his­toric loss­es that over­shad­ow hun­dreds of added staff in re­cent years.

Nei­ther cen­ter has ever record­ed net loss­es at fis­cal 2025 lev­els, and no quar­ter has been as low as the fourth quar­ter of this year. CDER lost 746 staffers (and gained six) — al­most three times as many loss­es as the third quar­ter — while CBER lost 194 em­ploy­ees (and gained four), ac­cord­ing to FDA da­ta up­dat­ed last week.

The FDA ex­o­dus in­cludes se­nior lead­er­ship, even as some teams were re­in­stat­ed fol­low­ing the April re­duc­tion in force (RIF) across the agency. It re­mains un­clear how these loss­es will af­fect the agen­cy's drug and bi­o­log­ic re­views or oth­er work, which have so far main­tained pace with years past. And it's un­clear if the lat­est da­ta re­leased by the FDA in­clude the more than 3,000 FDA staff cut by the RIF.

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3
by Zachary Brennan

Pfiz­er CEO Al­bert Bourla called Chi­na's bio­phar­ma ecosys­tem "re­mark­able," telling CN­BC's In­vest in Amer­i­ca fo­rum on Wednes­day that the US should fo­cus less on slow­ing down Chi­na and more on how to adapt to the new com­pe­ti­tion.

"They have done a tremen­dous job, not on­ly in in­vest­ing a lot, but in reg­u­la­to­ry changes, IP pro­tec­tions, fund­ing their na­tion­al in­sti­tu­tions, cre­at­ing phe­nom­e­nal uni­ver­si­ties," Bourla said of Chi­na, not­ing more patents were filed there than in the US last year.

To get ahead, the US needs "reg­u­la­to­ry changes, sta­bil­i­ty," Bourla said. "Tar­iffs and pric­ing were not help­ing," he added, re­fer­ring to the Trump ad­min­is­tra­tion's trade and drug cost pro­grams. Pfiz­er struck a deal with the Trump ad­min­is­tra­tion last month as part of the White House­'s "most fa­vored na­tion" pric­ing push.

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President Donald Trump speaks in the Oval Office on Oct. 16, 2025 (Andrew Caballero-Reynolds/AFP via Getty Images)
4
by Max Bayer

Pres­i­dent Don­ald Trump an­nounced a sweep­ing new ef­fort to broad­en IVF ac­cess by se­cur­ing “mas­sive dis­counts” on fer­til­i­ty drugs from EMD Serono, the lat­est deal in the White House­'s "most fa­vored na­tion" drug pric­ing push.

The an­nounce­ment Thurs­day at the White House al­so came with a brief up­date on how the ad­min­is­tra­tion plans to ne­go­ti­ate dis­counts for GLP-1 weight loss drugs, as well as the roll­out of the FDA's new pri­or­i­ty re­view vouch­ers that could pro­vide an even faster path­way for com­pa­nies to get prod­ucts as­sessed.

The IVF an­nounce­ment was the most sig­nif­i­cant ef­fort by the Trump ad­min­is­tra­tion to make good on a cam­paign pledge to widen ac­cess to fer­til­i­ty treat­ments, but falls short of Trump’s pre­vi­ous goal to make the treat­ments free.

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Mark Cuban at #HLTH25 (Michael Vanarey/HLTH)
5
by Zachary Brennan

Bil­lion­aire en­tre­pre­neur Mark Cuban and his heav­i­ly dis­count­ed, most­ly gener­ic drug on­line phar­ma­cy will link up with Pres­i­dent Don­ald Trump's in­com­ing on­line mar­ket­place TrumpRx, aim­ing to con­nect more pa­tients with bet­ter drug prices.

Cuban an­nounced the part­ner­ship on Sun­day at the HLTH con­fer­ence in Las Ve­gas, and called on the ad­min­is­tra­tion to go fur­ther on drug pric­ing re­form, par­tic­u­lar­ly around phar­ma­cy ben­e­fit man­agers.

"If you pull out the mon­ey go­ing to PBMs and their ver­ti­cal­ly in­te­grat­ed in­sur­ance com­pa­nies, then our price right now would be al­most as low, if not low­er, than the MFN prices that they're look­ing to do," Cuban told CN­BC.

The Trump-Cuban part­ner­ship fol­lows pledges from Pfiz­er, Am­gen and