Top Tweets for #Adcomm
FDA advisory committee meeting presentations are critical. With 25+ years of experience, SlideSource ensures your program has the best chance for success. #RegulatorySuccess #FDA #AdComm
https://t.co/Hmsys06G04
#ODAC votes 6-2 in favor of the benefit-risk profile of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) as a single-agent treatment for adults with HR-SMM!
#adcomm #fda #MultipleMyeloma
๐จ 4 FDA ODAC Meetings to Watch | May 20โ21, 2025
Drop your predictions in the comments.
#FDA #ODAC #biotech #oncology #clinicaltrials
Reading @US_FDA's briefing doc ahead of the #AdComm yesterday, one would've thought this was a straightforward vote against approval given multiple clinical trials failing to demonstrate efficacy. Many of the votes seem driven by wanting to offer anything even if it doesn't work.
Breaking: FDA adcomm votes 10-6 to support first potential drug for ultra-rare, fatal Barth syndrome - https://t.co/DqCeqhSYIQ
@US_FDA @FDA @nikchaudhry_ When considering how @US_FDA responds to recommendations regarding a drugโs market availability, this work suggests that temporary #AdComm recommendations are treated differently, though the nature of this difference remains unclear.
@US_FDA @FDA @nikchaudhry_ Main Finding 1: Of the 1,315 voting #AdComm members identified across 88 meetings, HALF were temporary members.
@US_FDA @FDA @nikchaudhry_ & co-authors combed through #AdComm meeting transcripts & member rosters spanning 2017 to 2021 to determine how often temporary voting members were added to meetings & how their votes aligned with @US_FDAโs final decisions.
Today's #AdComm meeting is coming close to an endโour colleague Hannah Clarke has created a truly robust live journal of the daylong deliberations.
Catch up on the discussion around the #sulopenem FDA application for UTIs at the link before the big vote! #IDTwitter #UroTwitter
๐งตThe FDA Antimicrobial Drugs Advisory Committee is set to meet today to discuss the submitted NDA for oral sulopenem for uncomplicated urinary tract infection.
Follow along with Urology Times' live report of the meeting below. #urology #urologist https://t.co/H7QqQNyVXy
This will be of selective and narrow interest.... But if you are responsible for executing an Advisory Committee (#AdComm) before @US_FDA, you want and need the @SlideSource team in your corner.
12/10 (Cue Carly Simon, "Nobody Does It Better")
Zevra today announced that an @US_FDA Advisory Committee meeting to review the New Drug Application for #arimoclomol as a first-in-class treatment for #NiemannPick Disease Type C will take place on August 2. #NPC #FDA #AdComm $ZVRA
More details at https://t.co/PwE4Rpvjsa
CRRIT in @Health_Affairs Forefront offers @US_FDA suggestions as part of the #AdComm reform process for the 3 areas identified in their recent listening session: 1) AdComm composition; 2) AdComm service as Special Govt Employees, & 3) public perception & understanding of AdComms.
In their new Forefront article, @reshmagar, @jsross119, @juliaetkin, + @jasonlschwartz from @YaleMed discuss key opportunities for the @US_FDA to maintain + enhance engagement with independent expert advisory committees to achieve the agencyโs goals. https://t.co/u1YlAHPm8E
@US_FDA questions data on MDMA-based therapy in PTSD ahead of #ADCOMM meeting
https://t.co/sA9ydabmuw via @Nicole_DeFeudis @SameiHuda @DrK_W1984 @sanilrege @RealJesseLuke
As @US_FDA #adcomm looms, @icer_review raises questions over @Lykos_PBC โs MDMA studies
https://t.co/MTPNInODCk via @Ayisha_Sharma97 @SameiHuda @DrK_W1984 @sanilrege @RealJesseLuke
@MemoryDoc @LonSchneiderMD @VincentPlanche @MadhavThambiset @smead2 @SuzanneESchind1 @DrTFromKC @seb_walsh @EWidera @ajlees @ProfRobHoward @dr_shibley @_michael_scholl @StefanoSensi14 @AlbertoEspay @nvillain_alz @KasperKepp @PhilAlz @Gill_Livingston @jfballenger @jasonkarlawish @JamesRuFletcher @AdamMBrickman @ManlyEpic @SFAckley @FortuneMagazine @TIME @ErinMPrater @TimeMagazineRS @FT @hannahkuchler @CTADconference @NIH @alzassociation @howard_gleckman @AmerGeriatrics @kathy_y_liu @r_merrick @nlundebjerg @NathanielChinMD @US_FDA @RaymondKoopmans @MaastrichtU @Kariem_Ezzat @DrBenUnderwood1 @NHSEngland @ObserverUK @EliLillyandCo gets @US_FDA June #ADCOMM for Alzheimer's drug donanemab, following earlier delay
https://t.co/wFDWtVeUHX via @ZacharyBrennan
Re: earlier tweet -- I don't mean that the #AdComm has been quiet; there've been lots of questions, but the overall "vibe" seems largely in favor of TriClip based on TRILUMINATE.
I will say, though, that the FDA advisory panels wrap up earlier when doctors have flights to catch! This (virtual) TriClip #AdComm is still going strong.
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