Lizzy Lawrence

Personal news: I'm joining the policy team as STAT's FDA reporter. I'll still cover the regulation of medical devices, but will also be focused on the agency as a whole. Excited to meet more folks in the space! Send tips to [email protected] statnews.com/2024-stat-inte…

Why did Semler Scientific, a device company helping insurers like UnitedHealth detect artery disease, start pouring all of its money into Bitcoin? We dug into this question, and why the company to abandoned its mission. More here: statnews.com/2025/06/24/sem…

EXCLUSIVE: Sarepta Therapeutics’ $SRPT Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says statnews.com/2025/07/22/fda… via @Jasonmmast and me.

Latest: A race to develop a new class of narcolepsy drugs could not only transform treatment for patients with the rare sleep disorder, but also many people with common health conditions like Alzheimer's and depression who struggle to stay awake. statnews.com/2025/07/22/nar…

Replimune $REPL skin cancer therapy rejected by FDA The decision is another signal that the FDA’s top regulator of cell and gene therapies is taking a hardened stance on new drug approvals statnews.com/2025/07/22/rep…

The FDA has a new drug center director: George Tidmarsh, a longtime biotech executive who has a background in oncology and pediatrics. statnews.com/2025/07/21/geo…

Peter Marks, the FDA official who overruled his own staff to approve Sarepta's Duchenne gene therapy, told STAT he agreed with the decision to pause shipments after recent deaths. “It does seem like it makes a fair amount of sense to get a better handle on the issues before…

FDA rejects Capricor’s $CAPR cell therapy for Duchenne muscular dystrophy The FDA decision follows the ouster of the agency’s chief regulator of cell and gene therapies statnews.com/2025/07/11/fda…

The FDA on Thursday published more than 200 letters that it sent to companies when it rejected their medicines — but only letters that have already been made public, for drugs that were ultimately approved. statnews.com/2025/07/10/fda…

The DOJ has issued “nearly 20 subpoenas” to clinics that provide gender-affirming care per DOJ's Chad Mizelle, who spoke at an all-day FTC workshop focused how the federal government might continue its crusade against trans health care. I watched: statnews.com/2025/07/09/doj…

On June 18, HHS said it would soon release ethics and conflict-of-interest documents for new vaccine advisers appointed by RFK Jr. to the ACIP. That group's first meeting came and went. Now, HHS appears to be backpedaling on its vow. New: statnews.com/2025/07/09/ken…

Breaking: HHS Secretary RFK Jr. has abruptly cancelled a meeting of the advisory committee that evaluates the nation's preventative services. No reason was provided via a letter viewed by STAT. statnews.com/2025/07/09/usp…

How the GOP, behind closed doors, pushed through health industry fears and passed historic Medicaid cuts statnews.com/2025/07/08/tru…

Exclusive: I spoke with 15 employees at the FDA to get a sense of how the agency is functioning since the April 1 layoffs. They described tanking morale and an intensifying staff exodus. Read more here: statnews.com/2025/07/07/fda…

#Breaking: The Senate passed a $4.5 trillion tax cut bill after last-minute changes to its health care provisions, as Republicans scrambled to get their party on board. trib.al/seVM5yZ

States are anxiously awaiting news about money for critical cancer-tracking and prevention work — including free breast & cervical cancer screenings for uninsured people. New contract year starts next week, but they've gotten no word from HHS. NEW: statnews.com/2025/06/26/cdc…

NEW: I obtained a recording of today's FDA drug center town hall. Psychedelics researcher Mike Davis will be deputy drug director. Also, in the wake of the April layoffs, the agency is still figuring out how to build back basic functions. statnews.com/2025/06/24/top…

Semler Scientific is one of the oddest companies I’ve ever reported on. A small company built around a questionable artery screening device has now fully pivoted into a *bitcoin speculator*. Casey Ross, @TaraBannow, @LizzyLaw_ , and I took a deep dive: statnews.com/2025/06/24/sem…

Exclusive: FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say My latest — endpoints.news/sources-fda-ch…

Interesting tidbit, for the times we're in: Vaccine developer Centivax has raised $45 million for a Series A round. The company plans to begin its first clinical trial of a universal flu vaccine early next year.

Updated this list again. In addition to the top drug regulator Jacqueline Corrigan-Curay and top gene therapy regulator Nicole Verdun, the drug center's top AI policy expert, Tala Fakhouri, is leaving this week. statnews.com/2025/04/03/fda…