Even for trans adults, care is hard to find: ‘I could not do it on my own’ State restrictions, Trump administration policies, and waning public support are further limiting adults' access to transgender care

I recently visited Indigo in Savannah to see how he and others at Georgia's only LGBTQ+ center are pushing to expand affirming care, even as it contracts elsewhere. www.statnews.com/2026/04/20/t...

FDA panel will meet to discuss allowing broader access to certain peptides The FDA will convene an outside panel of advisers to discuss whether to allow compounding pharmacies to manufacture certain peptides

NEW: The FDA will convene an advisory panel to discuss whether to allow broader access to peptides, a class of products that RFK Jr is a fan of:
www.statnews.com/2026/04/15/p...

FDA backs proposals to entice pharma companies to test, make drugs domestically From tariffs to incentives, the administration wants to push companies to manufacture drugs in the U.S.

W/ John Wilkerson: FDA backs proposals to entice pharma companies to test, make drugs domestically
www.statnews.com/2026/04/07/f...

Makary marks one year at FDA with focus on achievements in speech to staff The FDA commissioner praised staff and listed his accomplishments in a speech to workers.

NEW: FDA Commissioner Marty Makary marked one year at FDA with a focus on achievements in a speech to staff. He thanked career staff by name, and acknowledged the difficult of the April layoffs. But he said little on the agency’s more recent turmoil.
www.statnews.com/2026/04/01/f...

Political influence ‘a serious problem’ for FDA under Trump, former commissioner says “What's changed now is that there's a view in this administration that everything is political,” said Robert Califf, former FDA commissioner.

A writeup of my conversation with former FDA commissioner Rob Califf, written up by the excellent @danielpayne.bsky.social: www.statnews.com/2026/03/19/p...

FDA’s top infectious disease regulator to depart agency Adam Sherwat, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, is leaving the agency.

NEW: FDA’s top infectious disease regulator to depart agency
www.statnews.com/2026/03/18/f...

FDA and NIH announce more initiatives to reduce animal testing in drug development The HHS has made reducing animal testing a priority over the past year.

Today, HHS announced several initiatives to try and reduce reliance on animal testing in drug development, including new FDA guidance and new NIH grants:

www.statnews.com/2026/03/18/f...

Very excited to interview former FDA commissioner @robcaliff.bsky.social about the recent turmoil at FDA, from leadership upheaval to politicization of science, at STAT's Breakthrough Summit East in NYC on Thursday. You can register for tickets here: www.statnews.com/stat-summit-...

Health reporters react to "The Fugitive" YouTube video by STAT

Die Hard is a Christmas movie and The Fugitive is a St. Patrick's Day movie, and in ☘️ spirit I have a fun video this week. I asked some intrepid @statnews.com reporters how they would cover the pharma subplot of the classic 1993 thriller. youtu.be/zg0hIGl8Yt4

How STAT would cover 'The Fugitive' if its pharma scandal were real It's Oscar season, so we're bringing you a special STATus report on how we'd cover the drug scandal in "The Fugitive" if it were real.

I had a lot of fun filming this video with @alexhogan.bsky.social about how STAT would have covered the pharma-related events of "The Fugitive" if they were real. I think Dr. Kimble would have cleared his name a lot earlier if STAT reporters were on the case...
www.statnews.com/2026/03/13/f...

As controversial decisions mount, FDA shuns public advisory meetings The FDA is cutting back on public advisory committee meetings, even as the public and other stakeholders seek more transparency.

Two terrific #FDA related pieces by @lizzylawrence.bsky.social & @matthewherper.bsky.social. Matt's is a look at lessons to be drawn from Vinay Prasad's chaotic tenure; Lizzy's delves into the FDA's turning away from adcomms.
www.statnews.com/2026/03/08/v...
&
www.statnews.com/2026/03/09/f...

As controversial decisions mount, FDA shuns public advisory meetings The FDA is cutting back on public advisory committee meetings, even as the public and other stakeholders seek more transparency.

Despite recent controversial decisions, the FDA has stopped holding advisory committee meetings — which bring together regulators, companies, patients, and a panel of independent advisors to publicly discuss complex regulatory matters. I dug into why:
www.statnews.com/2026/03/09/f...

Vinay Prasad, key Makary ally and a focus of controversy at FDA, is leaving the agency Prasad has been involved in several controversial decisions related to rare disease treatments.

BREAKING: Vinay Prasad is leaving the FDA for the second time. First reported by the WSJ
www.statnews.com/2026/03/06/f...

FDA is ‘not convinced’ UniQure’s Huntington’s therapy has benefit, senior official says The FDA believes that an experimental therapy for Huntington’s disease from UniQure wasn't providing benefit for patients, a senior official told STAT.

NEW from @adamfeuerstein.bsky.social: FDA is ‘not convinced’ UniQure’s Huntington’s therapy has benefit, senior official says

www.statnews.com/2026/03/03/u...

Rare disease advocates fume over FDA's mixed signals Families facing rare diseases feel whiplash over shifting and contradictory decisions by the FDA.

Really excellent, nuanced piece from @jasonmast.bsky.social on what rare disease patient advocates, experts, and industry are making of the FDA's mixed signals: www.statnews.com/2026/02/26/r...

FDA Commissioner Marty Makary defends rare disease drug rejections, Vinay Prasad FDA Commissioner Marty Makary defended the agency’s recent rejections of rare disease drugs and one of his deputies, Vinay Prasad, in an interview with CNBC.

NEW: FDA Commissioner Marty Makary defended FDA's rare disease drug rejections, Vinay Prasad on CNBC this morning. He also appeared to disparage a Huntington’s disease treatment under review.
www.statnews.com/2026/02/26/m...

A rare disease drug was approvable, then it wasn’t. Inside a surprise rejection by the FDA Drugmakers thought they had the FDA's buy-in to approve a therapy to treat a type of cancer that can quickly turn deadly. The agency, however, rejected it.

Must read from @adamfeuerstein.bsky.social on the FDA deciding to reject a rare disease drug, despite the review team considering it approvable last year. The rejection comes as the FDA claims to be making regulatory flexibility in rare diseases a priority
www.statnews.com/2026/02/25/r...

FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications The FDA expects a flood of applications for a new "plausible mechanism pathway" for approval of bespoke gene-editing treatments.

NEW: FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications, w/ @jasonmast.bsky.social
www.statnews.com/2026/02/23/f...

Pharma lobbyists focus on a surprising new target: the FDA Lobbyists told STAT they believe the odds of approval go up if a decision can be spun as a win for the Trump administration.

NEW, w/ @danielpayne.bsky.social: How the pharma lobbying machine is trying to take advantage of a politicized FDA under the Trump administration www.statnews.com/2026/02/23/f...

In first speech to her FDA staff, Høeg says she’ll scrutinize RSV shots and SSRIs in pregnancy The top drug regulator at the FDA told staff she plans to question the safety of taking SSRIs in pregnancy and of RSV shots given to infants.

Scoop: In her first speech to FDA staff, top drug regulator Tracy Beth Høeg said she'll scrutinize RSV shots and SSRI use in pregnancy. She also said she'd like to bring her interest in vaccine policy into the drug center.
www.statnews.com/2026/02/19/t...

FDA taps AI executive to lead digital health center FDA has tapped a former executive from a health AI company to lead its digital health center.

NEW: FDA taps AI executive to lead digital health center, w/ @mariojoze.bsky.social
www.statnews.com/2026/02/19/f...

Hahah thanks Aunt Jill <3

STAT wins fourth Polk Award for reporting on impact of Trump on health STAT has won its fourth Polk Award in five years for documenting the Trump administration’s shakeup of the FDA, scientific research, and public health.

Honored to have won a George Polk award for my coverage of the turmoil at the FDA. The STAT team was also recognized for reporting on the Trump admin's impact on health and science. www.statnews.com/2026/02/18/s...

At drugmakers' forum, Oz gets a friendly embrace, while Makary faces tough questions Two of health secretary Robert F. Kennedy Jr.’s top lieutenants struck decidedly different tones at a forum held Tuesday by the pharmaceutical industry group PhRMA.

FDA Commissioner Marty Makary defended the agency's initial decision not to review the vaccine just yesterday, at a forum held by pharmaceutical industry group PhRMA: www.statnews.com/2026/02/17/p...

FDA reverses course, agrees to review Moderna’s flu vaccine The FDA reversed course and told Moderna it would review its application for a new flu vaccine, the company announced Wednesday.

BREAKING: FDA reverses course and will now review Moderna's flu vaccine, the company announced Wednesday www.statnews.com/2026/02/18/f...

At drugmakers' forum, Oz gets a friendly embrace, while Makary faces tough questions Two of health secretary Robert F. Kennedy Jr.’s top lieutenants struck decidedly different tones at a forum held Tuesday by the pharmaceutical industry group PhRMA.

RFK Jr. has long criticized pharma's influence on the federal government.

But Dr. Oz, talking to PhRMA today, took a different approach: welcoming the idea of closed-door meetings and urging industry leaders to work in the admin.

w/ @lizzylawrence.bsky.social

www.statnews.com/2026/02/17/p...

FDA rejects rare disease therapy from Disc Medicine, early recipient of commissioner’s voucher The FDA has rejected a rare disease therapy from Disc Medicine, an early recipient of a commissioner's voucher from the agency.

NEW: FDA rejects rare disease therapy from Disc Medicine, the first experimental drug to go through the commissioner's fast-track voucher program. STAT previously reported that top official Vinay Prasad became personally involved in this review.
www.statnews.com/2026/02/13/d...

New Flu Vax? FDA Says No Thanks - KFF Health News It’s been a busy week at the FDA, with a political appointee overruling agency scientists to reject an application for a new flu vaccine. Meanwhile, anti-abortion Republicans on Capitol Hill complain ...

on this week's #WTHealth podcast: @alicemiranda.bsky.social, @lizzylawrence.bsky.social, and @jackie-fortier.bsky.social on the controversies at FDA, new bill from Sens. Warren and Hawley (!) and more on immigration and health.
kffhealthnews.org/news/podcast...

This story has now been updated with comments from FDA Commissioner Marty Makary and others:

Prasad overruled FDA staff to reject Moderna's flu vaccine application The rejection is the latest instance of Vinay Prasad overruling career FDA scientists to place vaccines under harsher scrutiny.

Scoop: Top FDA official Vinay Prasad overruled the agency’s reviewers when he refused to accept Moderna’s application for a new influenza vaccine, STAT has learned.
www.statnews.com/2026/02/11/m...