Sue Sutter @PinkSheetSutter
Senior Editor, Citeline's Pink Sheet, covering US FDA drug and biologic regulation and approvals. Views are my own. @PharmaPinkSheet pink.citeline.com Washington, DC Joined June 2010-
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Sue Sutter retweeted
Interesting timing POST RFK testimony... HHS notifies states today that they must "respect state religious and conscience exemptions from vaccine mandates," as part of participation in Vaccines for Children Program which provides free vaccines to many. hhs.gov/press-room/hhs…
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Sue Sutter retweeted
Not just Offit ....A Pink Sheet review found 10 FDA advisory panel members recently pulled off committees despite having time left in their appointed terms. insights.citeline.com/pink-sheet/pro…
Sue Sutter retweeted
Is this the closest FDA has come to endorsing an off label use of a medicine or vaccine?
Is this the closest FDA has come to endorsing an off label use of a medicine or vaccine?
Sue Sutter retweeted
My resignation letter from CDC. Dear Dr. Houry, I am writing to formally resign from my position as Director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC), effective August 28, 2025, close of business.…
Summer Friday late afternoon news dump
Sue Sutter retweeted
SCOOP: The @PharmaPinkSheet's @PinkSheetSutter viewed Stealth's CRL and other elamipretide review docs to understand the issues plaguing the proposed Barth syndrome treatment: insights.citeline.com/pink-sheet/pro…
Sue Sutter retweeted
One of FDA's Oncology Division has lost what is essentially the equivalent of a full drug review team. It's malignant hematology review teams are expected to have a staff less than half the intended size as more staff depart this August. insights.citeline.com/pink-sheet/age…
Sue Sutter retweeted
The media is not equating Elevidys in DMD with SRP-9004 for LGMD as $SRPT suggests. We all realize these two gene therapies have differences, but the fact remains that they use the same AAV vector & that vector is what is linked to patient deaths. We are not confused about that.
The media is not equating Elevidys in DMD with SRP-9004 for LGMD as $SRPT suggests. We all realize these two gene therapies have differences, but the fact remains that they use the same AAV vector & that vector is what is linked to patient deaths. We are not confused about that.
Sue Sutter retweeted
$SRPT The FDA asked Sarepta to stop shipping Elevidys and the company refused. It’s hard to see what is gained by digging in their heals here. FDA also revoked the platform technology approval for the LGMD gene therapies. fda.gov/news-events/pr…
Sue Sutter retweeted
Today I'm thinking about this: when Hurricane Helene devastated Appalachia last year, my public radio colleagues in North Carolina, West Virginia, and Southwest Virginia stepped up. They broadcast the emergency alerts. They carried the official press conferences live.
US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much insights.citeline.com//pink-sheet/pr…
At $GSK Blenrep ODAC, @US_FDA designated federal officer reads new statement advising industry rep not to engage in "unseemly advocacy," mentions non-voting status at least half dozen times
Sue Sutter retweeted
FTC takes action against telemedicine firm NextMed over charges it used misleading prices, fake reviews, and deceptive weight loss claims to sell GLP-1 weight-loss programs: bit.ly/3IJdjDV /1
Sue Sutter retweeted
Best I can tell, these letters are already public as part of drug approval packages previously posted by FDA. So, maybe not such a BFD...
Best I can tell, these letters are already public as part of drug approval packages previously posted by FDA. So, maybe not such a BFD...
#ACIP will create new workgroups to look at cumulative childhood vaccine and adolescent vaccine schedules and vaccines that have not been subject to review in several years, such as hep B at birth
And we're underway at ACIP - member roster finally posted, 7 voting members total, 1 less than RFK initially annoucned. Michael Ross not listed as a member.
And we're underway at ACIP - member roster finally posted, 7 voting members total, 1 less than RFK initially annoucned. Michael Ross not listed as a member.
Sue Sutter retweeted
Cassidy is calling to delay the ACIP meeting.
Cassidy is calling to delay the ACIP meeting.
Sue Sutter retweeted
June ACIP agenda up. cdc.gov/acip/downloads… #vaccines
Sue Sutter retweeted
Senate HELP schedules hearing for cdc director nominee Monarez on day 1 of what should be a very unique ACIP…
"Resource constraints" - @US_FDA Commissioner Martin Makary has repeatedly said the proverbial trains are running on time at the agency despite the personnel losses. Evidence suggests otherwise.
"Resource constraints" - @US_FDA Commissioner Martin Makary has repeatedly said the proverbial trains are running on time at the agency despite the personnel losses. Evidence suggests otherwise.
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Andrew Dunn @AndrewE_Dunn
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Jessica Adams @RxRegA
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Vk @biotechinvstr
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Edward Nirenberg 🇺... @ENirenberg
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(((Liz Ditz))). Mask ... @lizditz
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gönül gönül @BrKezban
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Maxwell Young @maxwellcyoung
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AwardJudge @an2zbszkb966340
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St. Pierre @MSP_003
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Judith Macdonald @JudithMacd17582
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Brad Loncar @bradloncar
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Adam Feuerstein ✡�... @adamfeuerstein
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Matthew Herper @matthewherper
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Jacob Plieth @JacobPlieth
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Sarah Karlin-Smith @SarahKarlin
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Zach Brennan @ZacharyBrennan
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Scott Gottlieb, MD �... @ScottGottliebMD
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Mandy Jackson @ScripMandy
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Madeleine Armstrong @ByMadeleineA
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Jessica Adams @RxRegA
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Alexander Gaffney @AlecGaffney
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Dr. Kimryn Rathmell @NCIDirector
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Ethan J. Weiss @ethanjweiss
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Martin Kulldorff @MartinKulldorff
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268 Followers 342 Following covering FDA and drug pricing @InHealthPolicy • cinema on the side
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Pharma Ignite @PharmaIgnite
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NWS Juneau @NWSJuneau
10K Followers 139 Following Official X account for the National Weather Service Juneau. Details: https://t.co/ouonGFtGcp Latest SE Alaska weather #akwx - https://t.co/n1ly2F3o9i
Robert W Malone, MD @RWMaloneMD
1.3M Followers 2K Following Physician. Inventor. Scientist. Author. Speaker. Bioethicist. Journalist. https://t.co/a7h4RchtrM https://t.co/mi2O5s0Iaq https://t.co/zPulPcC57A
Adam Borecky, MD 🇺... @DrAdamBorecky
341 Followers 653 Following Psychiatrist | Clinical trials, new treatments, and bioethics | Commentary on psychiatry, science, and the future of mental health
FDAInsider @FDAInsider
817 Followers 65 Following For the latest news, analysis, and commentary on FDA policy and regulatory activity.
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Jake Scott, MD @jakescottMD
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Shannon Brownlee @ShannonBrownlee
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Eric Feigl-Ding @DrEricDing
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House Appropriations @HouseAppropsGOP
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House Appropriations ... @AppropsAmendmts
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INCUBATE @incub8coalition
265 Followers 232 Following We foster innovation, safeguard advancements, and amplify the results of life sciences investment.
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Senate Press Gallery @SenatePress
39K Followers 535 Following Established in 1841 for the reporters who cover the U.S. Senate.
Senate HELP Committee... @GOPHELP
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HF Collaboratory @hfcollaboratory
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Zachary Tracer @ZTracer
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Regulatory Affairs Pr... @RAPSorg
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Susan Winckler, CEO, ... @SusanWinckler
315 Followers 395 Following Mom (kids asked that 'their' label be first). Pharmacist. Attorney. Health care policy wonk.
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Association of Health... @AHCJ
10K Followers 2K Following AHCJ is an independent, nonprofit dedicated to improving health care journalism. Find us on Bluesky @healthjournalism.org
Isa Cueto @isabellacueto
3K Followers 3K Following Reporter for @statnews writing about chronic disease, MAHA & more. Message me on Signal isabellacueto.03 or find me elsewhere 🦋@isabellacueto.bsky.social
Charles Ornstein @charlesornstein
55K Followers 4K Following Managing editor/local at @ProPublica, past prez of @ahcj, Detroit Lions fan. Email: [email protected] Tweets are my own.
Jeff Stein @JStein_WaPo
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tony romm @TonyRomm
41K Followers 6K Following economic policy correspondent at the new york times. tips? signal: tonyromm.62
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Secretary Kennedy @SecKennedy
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Philadelphia Eagles @Eagles
4.0M Followers 155 Following Super Bowl LII & LIX Champions #FlyEaglesFly
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christymaginn @christymaginn
2K Followers 5K Following PR hack who works with tech and healthcare companies/coalitions
Mike Sisak @mikesisak
11K Followers 3K Following @AP reporter | law enforcement, courts, prisons and more | @newsmediaguild member | Find me below or on Bluesky: https://t.co/Am85pNhux4
U.S. Senator Bill Cas... @SenBillCassidy
97K Followers 2K Following Treated uninsured patients as a doctor in Louisiana’s charity hospital system, now serving the people of my state in the US Senate. Proud LSU grad! #GeauxTigers
Katherine Eban @KatherineEban
23K Followers 2K Following Award-winning investigative journo. Special Correspondent @VanityFair. NYT bestselling author. @CarnegieCorp fellow. @katherineeban.bsky.social. DM 4 Signal.
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