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…
Sarepta's crisis week: How questions over patient deaths put the biotech's future in jeopardy w/ @leilei_wuu, via @endpts endpoints.news/how-sareptas-c…
Very big deal here. $SRPT -12% today. @FDA under new management. That means Sarepta lost all its old supporters at the agency. Hats off to @ZacharyBrennan and @leilei for the scoop.
Exclusive: $SRPT would have to conduct new studies to get back on market, FDA official says - CBER review staff are 'unanimous' that Elevidys should never return to market endpoints.news/sarepta-would-…
Scoop: @BusinessInsider obtained an internal list of websites that could and couldn't be used for training Anthropic's latest AI models. Anthropic's contractor Surge AI left the list fully public on Google Docs. 'Sites you can use' include Bloomberg, Harvard, & the Mayo Clinic
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: