Sanofi $SNY receives approval for Tzield (teplizumab) to treat pediatric stage 3 T1D. Sanofi was awarded a Commissioner's National Priority Voucher for this indication but its unclear if this approval was still under the CNPV program as the decision has been delayed for months.

And say hi to me in White Oak 😀

SCOOP: $AMGN Fights @US_FDA On Tavneos Withdrawal Over Efficacy, Data Integrity Concerns insights.citeline.com/pink-s…

NEW: Court allows mail access to abortion pill for now. Justices Thomas and Alito dissented. supremecourt.gov/opinions/25…

The Senate appropriations committee has formally postponed its hearing tomorrow on FDA's budget. Makary had been preparing to testify.

Louisiana urges Supreme Court to leave in place order barring mailing of abortion pill scotusblog.com/2026/05/louis…

Young journos, if I can give you one piece of advice, let it be this: Do not normalize not having boundaries. Take it from someone who's been there - in the moment, it might feel OK sacrificing your vacation, your after-hours peace, your sanity. But it will catch up with you.

The FR notice will publish tomorrow and start the clock on whether to seek a hearing on the Tavneos withdrawal. One of my @PharmaPinkSheet stories: US FDA Details Data Manipulation, False Statements In Tavneos Withdrawal Request insights.citeline.com/pink-s…

Huge news: I have just been informed that healthcare is now one word in @APStylebook

Can you use a Commissioner's National Priority Voucher twice? @PinkSheetSutter flags another unique aspect of this program, which was launched without rulemaking or guidance and has raised a lot of questions about politicized decision-making. insights.citeline.com/pink-s…

CNPV For Life? Lilly’s Foundayo Filing Plans Suggest Voucher Can Span Indications — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/4yvuf vist.ly/4yvue

At a time when Congress and the FDA alike are pushing for more unannounced inspections of foreign firms, this feels like a notable shift in tactics that could increase public attention. fda.gov/inspections-complian…

Regarding dissolving the ACIP- I have now been told that this was a miscommunication, and in fact the decision about how to proceed has not been made, and dissolving and reforming remains one of options being considered.

STAT FDA reporter @LizzyLaw_ asks HHS chief counselor Chris Klomp about the turnover at the FDA. Klomp: “When I see turnover in any organization — could be the FDA, it could be another — it's worrisome…” #STATBreakthrough

On the clock: The White House has until 3/25 to nominate a new #CDC director. The Federal Vacancies Reform Act states a job like CDC director can only be filled on an acting basis for 210 days from the creation of the vacancy, though the clock stops if a nominee is named. sgp.fas.org/crs/misc/R44997.…

Special thanks to Canal Row Advisors' Michael Rogers and Doug Stearn for joining our Drug Fix podcast to chat about all things inspections insights.citeline.com/pink-s…

Just one point to emphasize: numerous reporters, myself included, asked for this briefing to be on the record. I'll be the first to admit I'm very liberal in my use of background attribution, especially if it's necessary to protect a source. This was not one of those cases.

The @US_FDA issued a final rule requiring all NDC codes to go from 10 digits to 12. Not effective until 2033 to allow for conversion, but I wonder if this will end up like DQSA implementation where problems forced delays in implementation beyond schedule: public-inspection.federalreg…

HHS and CDC said Ralph Abraham left his post as principal deputy director "to address unforeseen family obligations." Today, a week later, he's announced as Julia Letlow's campaign chair.

$QURE down this morning on comments made by FDA Commissioner Marty Makary to CNBC's Becky Quick. In a discussion about rare-disease drug approvals and Vinay Prasad, Makary said this: "I think there has been a bit of an effort to find a boogeyman to account for certain products that were not approved. For example, there was a product where the researchers drilled a burr hole, literally hole in people's skulls to interact inject intrathecally into the ventricle, a therapy the randomized control trial. At the end of the randomization period, it's found no benefit, and yet, this is one of the drugs that we were pressured to approve. Now, look, I have a lot of sympathy for those patients. There's nothing out there to offer them, but we're not going to go ahead and approve something like that that has morbidity associated with it."