Lizzy Lawrence
@lizzylawrence.bsky.social
Journalist @statnews.bsky.social, writing about the Food and Drug Administration. Tips welcome! Signal is lizzylaw.53
RFK Jr. has said he does not want to take vaccines away from Americans. But at a closed-door meeting of vaccine scientists in September, a top official at the FDA suggested doing just that. Here's how Vinay Prasad and Tracy Beth Høeg are reshaping vaccine regulation:
www.statnews.com/2025/11/12/f...
www.statnews.com/2025/11/12/f...
How two top FDA officials are quietly upending vaccine regulations
Vinay Prasad and Tracy Beth Høeg mix skepticism with new ways to define risk in pursuing sweeping changes to vaccine policy at the FDA.
www.statnews.com
November 12, 2025 at 1:42 PM
RFK Jr. has said he does not want to take vaccines away from Americans. But at a closed-door meeting of vaccine scientists in September, a top official at the FDA suggested doing just that. Here's how Vinay Prasad and Tracy Beth Høeg are reshaping vaccine regulation:
www.statnews.com/2025/11/12/f...
www.statnews.com/2025/11/12/f...
BREAKING: Longtime cancer regulator Rick Pazdur named director of drug center at FDA www.statnews.com/2025/11/11/f...
FDA taps Pazdur as new top drug regulator
Pazdur is a longtime FDA staffer and founded the agency's cancer therapy division
www.statnews.com
November 11, 2025 at 9:37 PM
BREAKING: Longtime cancer regulator Rick Pazdur named director of drug center at FDA www.statnews.com/2025/11/11/f...
NEW from @theresagaff.bsky.social and @chelseacirruzzo.bsky.social: FDA reverses decades-old warning on hormone therapy products for menopause
www.statnews.com/2025/11/10/f...
www.statnews.com/2025/11/10/f...
FDA reverses decades-old warning on hormone therapy products for menopause
The FDA is reversing a 2003 decision that put a stringent warning on hormone therapy products for menopausal women, saying that the treatments offer heart, brain, and bone health benefits.
www.statnews.com
November 10, 2025 at 5:07 PM
NEW from @theresagaff.bsky.social and @chelseacirruzzo.bsky.social: FDA reverses decades-old warning on hormone therapy products for menopause
www.statnews.com/2025/11/10/f...
www.statnews.com/2025/11/10/f...
Reposted by Lizzy Lawrence
A Sharon Begley byline, almost 5 years after her death.
Upon hearing the news James Watson had died, a STAT reporter said in our Slack, "I wish I could read what Sharon would have written."
Incredible news: Sharon in fact did pre-write a Watson obit. And it is masterful and excoriating.
🧪🧬🧫
Upon hearing the news James Watson had died, a STAT reporter said in our Slack, "I wish I could read what Sharon would have written."
Incredible news: Sharon in fact did pre-write a Watson obit. And it is masterful and excoriating.
🧪🧬🧫
James Watson, dead at 97, was a scientific legend and a pariah among his peers
James Watson, the co-discoverer of the structure of DNA who died Thursday at 97, was a scientific legend and a pariah among his peers.
www.statnews.com
November 8, 2025 at 1:39 PM
A Sharon Begley byline, almost 5 years after her death.
Upon hearing the news James Watson had died, a STAT reporter said in our Slack, "I wish I could read what Sharon would have written."
Incredible news: Sharon in fact did pre-write a Watson obit. And it is masterful and excoriating.
🧪🧬🧫
Upon hearing the news James Watson had died, a STAT reporter said in our Slack, "I wish I could read what Sharon would have written."
Incredible news: Sharon in fact did pre-write a Watson obit. And it is masterful and excoriating.
🧪🧬🧫
Here is how the search for top drug regulator is going: FDA deputy commissioner Sara Brenner sent an email to CDER staff today soliciting applications to lead the center. More here:
www.statnews.com/2025/11/07/f...
www.statnews.com/2025/11/07/f...
FDA broadens search for new top drug regulator after early setbacks
George Tidmarsh left the agency amid accusations of misusing his authority and after clashing with another top official.
www.statnews.com
November 7, 2025 at 8:51 PM
Here is how the search for top drug regulator is going: FDA deputy commissioner Sara Brenner sent an email to CDER staff today soliciting applications to lead the center. More here:
www.statnews.com/2025/11/07/f...
www.statnews.com/2025/11/07/f...
NEW: FDA announces six new recipients of priority vouchers, including GLP-1s from Eli Lilly and Novo Nordisk. Most of the recipients have already received some type of FDA approval.
www.statnews.com/2025/11/06/f...
www.statnews.com/2025/11/06/f...
FDA announces next round of priority review vouchers
The FDA announced the second batch of companies being granted a “Commissioner’s National Priority Voucher,” a ticket to speedier drug reviews.
www.statnews.com
November 6, 2025 at 7:24 PM
NEW: FDA announces six new recipients of priority vouchers, including GLP-1s from Eli Lilly and Novo Nordisk. Most of the recipients have already received some type of FDA approval.
www.statnews.com/2025/11/06/f...
www.statnews.com/2025/11/06/f...
Reposted by Lizzy Lawrence
Important new analysis from @matthewherper.bsky.social and @lizzylawrence.bsky.social about the ongoing situation at FDA. This quote from an agency staffer sums up the potential concerns. www.statnews.com/2025/11/04/f...
November 4, 2025 at 2:41 PM
Important new analysis from @matthewherper.bsky.social and @lizzylawrence.bsky.social about the ongoing situation at FDA. This quote from an agency staffer sums up the potential concerns. www.statnews.com/2025/11/04/f...
What does all this chaos at FDA mean for biotech and for patients? @matthewherper.bsky.social and I talked to experts, and have more on the drama between the drug and biologics center leaders — "We now have FDA "Mean Girls" burn books out in the open," a source said. www.statnews.com/2025/11/04/f...
Experts worry FDA’s credibility is being shredded by scandal and 'soap opera'
Experts worry that the FDA’s credibility is being shredded by scandal and "soap opera."
www.statnews.com
November 4, 2025 at 2:39 PM
What does all this chaos at FDA mean for biotech and for patients? @matthewherper.bsky.social and I talked to experts, and have more on the drama between the drug and biologics center leaders — "We now have FDA "Mean Girls" burn books out in the open," a source said. www.statnews.com/2025/11/04/f...
Interesting, and perhaps unsurprising given tumult at FDA — FDA Commissioner Marty Makary was supposed to speak at
@wsj.com's Future of Health event today. At some point today, he was removed from the agenda.
@wsj.com's Future of Health event today. At some point today, he was removed from the agenda.
November 3, 2025 at 10:06 PM
Interesting, and perhaps unsurprising given tumult at FDA — FDA Commissioner Marty Makary was supposed to speak at
@wsj.com's Future of Health event today. At some point today, he was removed from the agenda.
@wsj.com's Future of Health event today. At some point today, he was removed from the agenda.
NEW: Andrew Joseph has the deep dive into the lawsuit filed by biotech investor Kevin Tang against top drug regulator George Tidmarsh, who resigned yesterday. Read more here:
www.statnews.com/2025/11/03/g...
www.statnews.com/2025/11/03/g...
Lawsuit against top FDA drug regulator is packed with incendiary texts, emails
A lawsuit filed against George Tidmarsh, who resigned from a top FDA post on Sunday, includes a series of incendiary texts and emails
www.statnews.com
November 3, 2025 at 4:59 PM
NEW: Andrew Joseph has the deep dive into the lawsuit filed by biotech investor Kevin Tang against top drug regulator George Tidmarsh, who resigned yesterday. Read more here:
www.statnews.com/2025/11/03/g...
www.statnews.com/2025/11/03/g...
Reposted by Lizzy Lawrence
To summarize:
- The FDA's top drug regulator is out.
- He and the FDA's top biologics official are in open warfare.
- A lawsuit accuses him of extortion, and he accuses a former associate of the same.
Via @lizzylawrence.bsky.social @adamfeuerstein.bsky.social
www.statnews.com/2025/11/02/f...
- The FDA's top drug regulator is out.
- He and the FDA's top biologics official are in open warfare.
- A lawsuit accuses him of extortion, and he accuses a former associate of the same.
Via @lizzylawrence.bsky.social @adamfeuerstein.bsky.social
www.statnews.com/2025/11/02/f...
FDA’s top drug regulator resigns amid investigation
George Tidmarsh, the FDA's top drug regulator, has been placed on leave after being accused of abusing his regulatory authority, STAT has learned.
www.statnews.com
November 3, 2025 at 12:40 AM
To summarize:
- The FDA's top drug regulator is out.
- He and the FDA's top biologics official are in open warfare.
- A lawsuit accuses him of extortion, and he accuses a former associate of the same.
Via @lizzylawrence.bsky.social @adamfeuerstein.bsky.social
www.statnews.com/2025/11/02/f...
- The FDA's top drug regulator is out.
- He and the FDA's top biologics official are in open warfare.
- A lawsuit accuses him of extortion, and he accuses a former associate of the same.
Via @lizzylawrence.bsky.social @adamfeuerstein.bsky.social
www.statnews.com/2025/11/02/f...
Story has more details now about Tidmarsh's feud with biotech investor Kevin Tang. Tang's company sued Tidmarsh today, accusing him of a "longstanding personal vendetta":
BREAKING: FDA’s top drug regulator George Tidmarsh has been placed on leave after being accused of abusing his regulatory authority - but also after he questioned the commissioner's plan to speed approvals, and clashed with Vinay Prasad. More here:
www.statnews.com/2025/11/02/f...
www.statnews.com/2025/11/02/f...
FDA’s top drug regulator placed on leave amid investigation
George Tidmarsh, the FDA's top drug regulator, has been placed on leave after being accused of abusing his regulatory authority, STAT has learned.
www.statnews.com
November 2, 2025 at 11:47 PM
Story has more details now about Tidmarsh's feud with biotech investor Kevin Tang. Tang's company sued Tidmarsh today, accusing him of a "longstanding personal vendetta":
BREAKING: FDA’s top drug regulator George Tidmarsh has been placed on leave after being accused of abusing his regulatory authority - but also after he questioned the commissioner's plan to speed approvals, and clashed with Vinay Prasad. More here:
www.statnews.com/2025/11/02/f...
www.statnews.com/2025/11/02/f...
FDA’s top drug regulator placed on leave amid investigation
George Tidmarsh, the FDA's top drug regulator, has been placed on leave after being accused of abusing his regulatory authority, STAT has learned.
www.statnews.com
November 2, 2025 at 10:11 PM
BREAKING: FDA’s top drug regulator George Tidmarsh has been placed on leave after being accused of abusing his regulatory authority - but also after he questioned the commissioner's plan to speed approvals, and clashed with Vinay Prasad. More here:
www.statnews.com/2025/11/02/f...
www.statnews.com/2025/11/02/f...
Reposted by Lizzy Lawrence
2. Also please read @lizzylawrence.bsky.social's piece on the impact Vinay Prasad is having on #FDA's vaccines division, where between Prasad pushing leaders out and people heading for the exits, there are concerns about #CBER's capacity to function. www.statnews.com/2025/10/31/v...
Under Vinay Prasad, employees at a key FDA center fear speaking out, look for the exits
Exclusive: Vinay Prasad has rattled FDA staff by expanding his power and pushing out senior leaders.
www.statnews.com
October 31, 2025 at 7:42 PM
2. Also please read @lizzylawrence.bsky.social's piece on the impact Vinay Prasad is having on #FDA's vaccines division, where between Prasad pushing leaders out and people heading for the exits, there are concerns about #CBER's capacity to function. www.statnews.com/2025/10/31/v...
EXCLUSIVE: A slow-boiling feud between Vinay Prasad and his staff at the FDA is threatening the future of the center that regulates the nation’s vaccines, biological products, and blood supply. Read more here:
www.statnews.com/2025/10/31/v...
www.statnews.com/2025/10/31/v...
Under Vinay Prasad, employees at a key FDA center fear speaking out, look for the exits
Exclusive: Vinay Prasad has rattled FDA staff by expanding his power and pushing out senior leaders.
www.statnews.com
October 31, 2025 at 12:17 PM
EXCLUSIVE: A slow-boiling feud between Vinay Prasad and his staff at the FDA is threatening the future of the center that regulates the nation’s vaccines, biological products, and blood supply. Read more here:
www.statnews.com/2025/10/31/v...
www.statnews.com/2025/10/31/v...
NEW: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs, via @danielpayne.bsky.social www.statnews.com/2025/10/29/f...
FDA moves to ease path for biosimilars as Trump seeks to cut drug costs
The FDA is aiming to make it easier to get biosimilar drugs approved.
www.statnews.com
October 29, 2025 at 7:25 PM
NEW: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs, via @danielpayne.bsky.social www.statnews.com/2025/10/29/f...
NEW: I talked with the nine companies that won FDA priority review vouchers and asked them how they did it: www.statnews.com/2025/10/24/h...
How the first nine drug companies won priority review vouchers from Marty Makary’s FDA
The winners include a gene therapy for a rare form of deafness, a drug for vaping addiction, and a generic antibiotic.
www.statnews.com
October 24, 2025 at 2:52 PM
NEW: I talked with the nine companies that won FDA priority review vouchers and asked them how they did it: www.statnews.com/2025/10/24/h...
Reposted by Lizzy Lawrence
New reporting now in this updated story —
EMD Serono had been discussing IVF with the administration for months, even before Trump was sworn in.
Those conversations culminated in a deal this week.
But more is on the horizon, including new U.S. investment announcements from the company.
EMD Serono had been discussing IVF with the administration for months, even before Trump was sworn in.
Those conversations culminated in a deal this week.
But more is on the horizon, including new U.S. investment announcements from the company.
Trump announces plan to expand fertility treatment coverage alongside latest pharma deal
www.statnews.com/2025/10/16/t...
www.statnews.com/2025/10/16/t...
Trump announces plan to expand fertility treatment coverage alongside latest pharma deal
The Trump administration has struck a deal with EMD Serono to lower drug prices — part of a larger push from the administration to expand coverage and improve affordability for fertility services.
www.statnews.com
October 17, 2025 at 2:45 PM
New reporting now in this updated story —
EMD Serono had been discussing IVF with the administration for months, even before Trump was sworn in.
Those conversations culminated in a deal this week.
But more is on the horizon, including new U.S. investment announcements from the company.
EMD Serono had been discussing IVF with the administration for months, even before Trump was sworn in.
Those conversations culminated in a deal this week.
But more is on the horizon, including new U.S. investment announcements from the company.
ICYMI: FDA announces first nine recipients of priority drug review vouchers
www.statnews.com/2025/10/16/f...
www.statnews.com/2025/10/16/f...
FDA announces first nine recipients of priority drug review vouchers
FDA announced the first nine recipients of priority review vouchers, which offers expedited drug review to products aligned with national health priorities.
www.statnews.com
October 17, 2025 at 2:37 AM
ICYMI: FDA announces first nine recipients of priority drug review vouchers
www.statnews.com/2025/10/16/f...
www.statnews.com/2025/10/16/f...
From @adamfeuerstein.bsky.social rstein's excellent panel on FDA & biotech uncertainty yesterday, where Replimune's and Capricor's CEOs talked about their FDA rejections earlier this year:
www.statnews.com/2025/10/16/f...
www.statnews.com/2025/10/16/f...
Biotech leaders say uncertainty at FDA threatens drug development
The FDA's rejections of Replimune and Capricor therapies show how instability threatens biotech innovation, CEOs say.
www.statnews.com
October 16, 2025 at 4:54 PM
From @adamfeuerstein.bsky.social rstein's excellent panel on FDA & biotech uncertainty yesterday, where Replimune's and Capricor's CEOs talked about their FDA rejections earlier this year:
www.statnews.com/2025/10/16/f...
www.statnews.com/2025/10/16/f...
Reposted by Lizzy Lawrence
#Breaking: Medicare payments to doctors paused as government shutdown drags on www.statnews.com/2025/10/15/c...
Medicare payments to doctors paused as government shutdown drags on
The Centers for Medicare and Medicaid Services is pausing Medicare payments to doctors, as negotiations tied to the government shutdown drag on.
www.statnews.com
October 15, 2025 at 10:34 PM
#Breaking: Medicare payments to doctors paused as government shutdown drags on www.statnews.com/2025/10/15/c...
Re-upping our FDA leadership departure tracker, which we updated yesterday. At least 10 top officials have left the agency since June. Feel free to reach out if there are others I have missed.
www.statnews.com/2025/04/03/f...
www.statnews.com/2025/04/03/f...
A running list of senior FDA officials who have left the agency
Here is a running list of senior FDA officials who have left the agency recently.
www.statnews.com
October 15, 2025 at 3:06 PM
Re-upping our FDA leadership departure tracker, which we updated yesterday. At least 10 top officials have left the agency since June. Feel free to reach out if there are others I have missed.
www.statnews.com/2025/04/03/f...
www.statnews.com/2025/04/03/f...
Exclusive: How political pressure is shaping the work of the FDA, from searching for autism treatments to heavily focusing on Covid-19 vaccine adverse events. Read for more details on how the leucovorin decision came about, in particular:
www.statnews.com/2025/10/14/f...
www.statnews.com/2025/10/14/f...
Inside FDA, career staffers describe how political pressure is influencing their work
Current and former FDA staff said the level of involvement of political officials in nitty-gritty regulatory matters is unprecedented.
www.statnews.com
October 14, 2025 at 1:09 PM
Exclusive: How political pressure is shaping the work of the FDA, from searching for autism treatments to heavily focusing on Covid-19 vaccine adverse events. Read for more details on how the leucovorin decision came about, in particular:
www.statnews.com/2025/10/14/f...
www.statnews.com/2025/10/14/f...
NEW: Peter Marks, former top vaccine regulator ousted by RFK Jr. , is joining Eli Lilly.
www.statnews.com/2025/10/07/p...
www.statnews.com/2025/10/07/p...
Peter Marks, FDA vaccine regulator ousted by RFK Jr., joins Eli Lilly
Peter Marks, the former top vaccine regulator at the FDA, has joined Eli Lilly — a move likely to rile up critics of the revolving door between FDA and industry
www.statnews.com
October 7, 2025 at 6:44 PM
NEW: Peter Marks, former top vaccine regulator ousted by RFK Jr. , is joining Eli Lilly.
www.statnews.com/2025/10/07/p...
www.statnews.com/2025/10/07/p...
Reposted by Lizzy Lawrence
My first post as head of KSJ! Our first public event. This Thursday. Cambridge. Science journalism in a time of crisis. It's going to be 🔥. Join me and @katherinejwu.com @aniloza.bsky.social @sarareardon.bsky.social @akuchment.bsky.social @jeremyfaust.bsky.social and @edenmedina.bsky.social
October 7, 2025 at 12:09 PM
My first post as head of KSJ! Our first public event. This Thursday. Cambridge. Science journalism in a time of crisis. It's going to be 🔥. Join me and @katherinejwu.com @aniloza.bsky.social @sarareardon.bsky.social @akuchment.bsky.social @jeremyfaust.bsky.social and @edenmedina.bsky.social