Cingulate Inc.’s SVP of Market Access Rick Arce discusses the role of step edits and prior authorizations for CTx-1301. $CING #PrecisionTimedRelease #PTR #Biotech #FDA #PDUFA #NDA youtube.com/shorts/n0xtr...
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#PDUFA
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Cingulate CEO Shane Schaffer talks about the financing environment for small cap life sciences companies & its recent raise. $CING
#PrecisionTimedRelease #PTR #NASDAQ #Biotech #BioPharma #FDA #FDAApproval #PDUFA #NDA #DrugDelivery #ExtendedRelease #ControlledRelease
youtube.com/shorts/CZ-Cn...
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EVP and Chief Commercial Officer Bryan Downey describes Cingulate’s sales and marketing strategy for CTx-1301. $CING #CTx-1301 #ADHD #PrecisionTimedRelease #PTR #NASDAQ #Biotech #BioPharma #FDA #FDAApproval #PDUFA #NDA #DrugDelivery #ExtendedRelease #ControlledRelease
youtube.com/shorts/sVbvZ...
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Cingulate’s SVP of Market Access Rick Arce makes the case for CTx-1301 to payors we move towards the May 31 2026 target action date.
$CING
#PrecisionTimedRelease #PTR #NASDAQ #Biotech #BioPharma #FDA #FDAApproval #PDUFA #NDA #DrugDelivery
youtube.com/shorts/aKWRi...
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Biogen’s high-dose nusinersen published in Nature Medicine; DEVOTE shows significant CHOP-INTEND improvement in SMA
stellanews.life/technology/8...
#SMA #Nusinersen #SPINRAZA #DEVOTE #CHOPINTEND #FDA #PDUFA
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EVP & Chief Commercial Officer Bryan Downey explains Cingulate’s commercialization efforts and how young adult women fit in as patients, caregivers & decision makers for family health care.
$CING
CTx-1301 #ADHD #PTR #NASDAQ #Biotech #BioPharma #FDA #PDUFA #NDA
youtube.com/shorts/UVKJ3...
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EVP and Chief Commercial Officer Bryan Downey explains Indegene’s role in Cingulate’s commercialization efforts for CTx-1301 in ADHD. $CING
#PrecisionTimedRelease #PTR #NASDAQ #Biotech #BioPharma #FDA #FDAApproval #PDUFA #NDA #ControlledRelease #Dexmethylphenidate
youtube.com/shorts/UnnYM...
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As we advance to CTx-1301’s 31May26 target action date, Cingulate SVP of Market Access Rick Arce explains the process of getting payors on board. $CING
#PrecisionTimedRelease #PTR #NASDAQ #Biotech #BioPharma #FDA #FDAApproval #PDUFA #NDA #DrugDelivery #Dexmethylphenidate
youtube.com/shorts/T-fYV...
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As we move towards CTx-1301’s 31May26 target action date, Cingulate CEO Shane Schaffer describes payors reactions to the medicine. $CING
#PrecisionTimedRelease #PTR #NASDAQ #Biotech #BioPharma #FDA #PDUFA #NDAFails
youtube.com/shorts/nIzin...
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Cingulate Inc.'s NDA was accepted by the #FDA & assigned a #PDUFA date in May 2026. Dr. Childress, principal investigator on the CTx-1301 trials, explains how an approval of this medicine can address unmet needs for #ADHD patients.
youtu.be/kFxtW_Mc1cQ
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Our written comment about user fees for drugs and biologics criticizes the current #PDUFA for pushing speedy approvals and lower #FDA standards to please industry, instead of ensuring safety and efficacy. #MAHA Read more: www.center4research.org/nchr-pdufa-w...
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Welcome to the new FDA. Here's your playbook!
Rachel Sherman, fomer Principal Deputy Commissioner of the #FDA, presents best practices for working effectively and efficiently across current agency changes.
Read the article today at >> bit.ly/3Uy0jDM #Biorasi2025 #PDUFA #RWE #21CFR1075
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What's the #FDA telling you?
Learn how to read the signals in our latest white paper, featuring the esteemed Rachel Sherman, fomer Principal Deputy Commissioner of the FDA. Don't wait! Read the article today at >> bit.ly/3TQLwE7 #Biorasi2025 #clinicaltrials #PDUFA #21CFR1075
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🚨 FDA delays making headlines, but are they really worse than usual?
Our analysis at @inThought shows 2025 PDUFA delays aren't exceeding historical norms… yet.
Read: FDA Uncertainty: 2025 PDUFA Misses & Ad Board Trends
🔗 inthought.com/in-the-news/
#FDA #PDUFA #biotech #pharma #regulatory
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Pharmalot.. Pharmalittle.. Good Morning: We’re reading about FDA eyeing PDUFA changes, compounded weight loss drugs & more news.. statnews.com/pharmalot/20... #pharma #biotech #FDA #PDUFA #Colorado #weight #obesity #compounding #pharmacy #UK #Pfizer #Lilly #NovoNordisk
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FYI: LucidQuest Views >>> Rare Diseases Weekly News – May 1st 2025 #News #elafibranor #ZEVASKYN #PDUFA #genetherapy Comment below!
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ICYMI: LucidQuest Views >>> Rare Diseases Weekly News – May 1st 2025 #News #elafibranor #ZEVASKYN #PDUFA #genetherapy Comment below!
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LucidQuest Views >>> Rare Diseases Weekly News – May 1st 2025 #News #elafibranor #ZEVASKYN #PDUFA #genetherapy Comment below!
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#FDA missed its first #PDUFA deadline in a while.
Novavax non-mRNA COVID19 vaccine!!! ir.novavax.com/press-releas...
Could it be the consequence of recent chaos at agency, or is it because it is about a #vaccine?
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What are the odds that #PDUFA dates like upcoming #$ALNY vutri in ATTR-CM are missed because of 'inadvertent' #FDA firings?
Thinking of selling #options into these dates...
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In some good news, the FDA will conduct an accelerated review of Gilead's new drug application for #lenacapavir as #PrEP, the #PDUFA date is June 19.
www.gilead.com/news/news-de...
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Foresee Pharmaceuticals Sets PDUFA Goal Date for CAMCEVI's 3-Month Injectable Formula #Taiwan #Taipei #Foresee_Pharmaceuticals #CAMCEVI #PDUFA
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BioPharmCatalyst Weekly #Watchlist #stocks
Upcoming Small/Mid-Cap #PDUFA #Catalysts
$NBIX $LXRX $AZN $BGNE $SLNO $APLT $IONS $PFE $MIRM $JNJ $HALO
www.biopharmcatalyst.com/news/2024/up...
#biotech
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Proud to have joined with 25 other California organizations in support of a clean reauthorization of #PDUFA! #Congress must reauthorize PDUFA so patients can continue accessing the latest treatments @RepRaulRuizMD @RepCardenas @RepScottPeters
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We want to express our appreciation for @RepRaulRuizMD' team for meeting with us to talk about #PDUFA. Since Congress passed the first PDUFA in 1992, new medicines' average approval time reduced to just 10 months - so patients don't have to wait as long for innovative treatments.
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Thank You to @RepCardenas' office for meeting with us to discuss the importance of a timely and clean reauthorization of #PDUFA VII. #Liver patients need PDUFA to continue accessing life-saving medicines and therapies.
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Some context for upcoming @ScottGottliebMD hearings and #PDUFA reauth - FDA still faster than EMA: http://www.nejm.org/doi/full/10.1056/NEJMc1700103 with @jsross119
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But many confounding factors, e.g. intrinsic differences in the characteristics of drugs approved by #FDA before/after #PDUFA. [2/2]
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New @Health_Affairs piece points to increase in black-box warnings and safety withdrawals post-#PDUFA: content.healthaffairs.org/content/33/8/1453.abstra... [1/2]
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