Drew Armstrong
@ArmstrongDrew
Executive Editor, Endpoints News (@endpts). Got a confidential tip? Message me on Signal: DrewArmstrong.39
🎙️ Today on Endpoints News Post-Hoc Live, we're talking about @Sarepta. I'll be joined at 1:30pm by @Jared_Whitlock and @leilei_wuu about the company's showdown with the FDA over its hashtag #duchenne gene therapy + what comes next endpoints.news/endpoints-live…
This is a fairly shocking detail in @adamfeuerstein and @Jasonmmast's latest story on why the FDA acted when it did in response to most recent $SRPT patient death:
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.
Sarepta halts US shipments of Duchenne therapy, bowing to FDA endpoints.news/sarepta-halts-…
‘This is outrageous': @US_FDA 's mRNA vaccine approvals are angering Kennedy’s MAHA allies endpoints.news/fdas-continued… via @maxonwifi
FDA organized a panel focused on the use of antidepressants during pregnancy but some of the panelists they picked "sell expensive services like a 'tapering coach' to help manage SSRI withdrawal symptoms" & claim the drugs = "higher rates of autism." Story by @MaxGelman @endpts
PR firms sometimes like to complain about media headlines referring to complete response letters as rejections, too. The argument always struck me as a bit silly. If a CRL isn't a rejection, then can the FDA ever be said to have rejected a drug approval application?
On FDA, some of you saw the news about Makary & KalVista last month. The drug was shortly approved after the @endpts story broke which helped prevent a potential investigation or congressional hearing re: FDA. Here's what the new head of CDER posted on Linked In at the time:
Our man @maxonwifi, from the front lines of MAHA's growing civil war over mRNA:
My latest feature, on the growing revolt within key parts of MAHA after three mRNA vaccine approvals under @SecKennedy and @DrMakaryFDA. endpoints.news/fdas-continued…
¯\_(ツ)_/¯
On FDA, some of you saw the news about Makary & KalVista last month. The drug was shortly approved after the @endpts story broke which helped prevent a potential investigation or congressional hearing re: FDA. Here's what the new head of CDER posted on Linked In at the time:
Starting now!
(reposted w/ link) Returned from Japan at midnight ➡️@endpts Post-Hoc Live about @Sarepta at 1:30 pm ET today. Join me, @ArmstrongDrew and @Jared_Whitlock to catch up on all that's happened around Sarepta and its DMD gene therapy last week endpoints.news/endpoints-live…
See you shortly!
🎙️ Today on Endpoints News Post-Hoc Live, we're talking about @Sarepta. I'll be joined at 1:30pm by @Jared_Whitlock and @leilei_wuu about the company's showdown with the FDA over its hashtag #duchenne gene therapy + what comes next endpoints.news/endpoints-live…
(reposted w/ link) Returned from Japan at midnight ➡️@endpts Post-Hoc Live about @Sarepta at 1:30 pm ET today. Join me, @ArmstrongDrew and @Jared_Whitlock to catch up on all that's happened around Sarepta and its DMD gene therapy last week endpoints.news/endpoints-live…
I'm looking forward to the conversation, and please be in touch with any tips you might have. Signal: jaredwhitlock.73
🎙️ Today on Endpoints News Post-Hoc Live, we're talking about @Sarepta. I'll be joined at 1:30pm by @Jared_Whitlock and @leilei_wuu about the company's showdown with the FDA over its hashtag #duchenne gene therapy + what comes next endpoints.news/endpoints-live…
Peter Marks -- who controversially helped push through Sarepta's therapy -- tells @maxonwifi that pausing sales of Elevidys makes sense: endpoints.news/peter-marks-sa…
