Top Tweets for #PriorityReview
Breaking News in MOGAD: FDA grants Priority Review for Enspryng (satralizumab) for MOGAD.
For full details and the official press release:
https://t.co/0tXBhPoIp0
#MOGAD #raredisease #patientadvocacy #BreakingNews #enspryng #Satralizumab #FDA #PriorityReview
Over the past year, #RareDisease advocates sent thousands of messages to #Congress to pass the #GiveKidsAChanceAct, which would reauthorize the soon-to-expire Rare #Pediatric Disease #PriorityReview Voucher Program.
Yesterday, the #Senate attempted to pass the bill via unanimous consent. Despite strong bipartisan support, the vote failed.
While #NORD is disappointed in this outcome, we will continue to fight for these important policies when the #Senate returns in January.
Learn about the proven impact this program has had on treatment development for children with rare diseases: https://t.co/l8tsqoPXPE
FDA Grants Priority Review to Liso-Cel for R/R Marginal Zone Lymphoma
@US_FDA #MZL #PriorityReview
https://t.co/F3IQHiWbpI
FDA #priorityreview for taletrectinib based on TRUST-I&II pooled data. #PDUFA Jun 23'25.
It demonstrated highest ORR and mPFS of any ROS1 inhibitor in 1L(TKI-naïve) setting
Recent #NCCNguidelines update creates substantial #MarketOpportunity
#LungCancer #NSCLC #Oncology #Pharma
🔥 @JCO_ASCO @ASCO 🆙
✅TRUST: Taletrectinib in ROS1+ NSCLC
🎯TKI-naïve/pretreated: ORR 88.8/55.8%, Intracranial-ORR 76.5/65.6%, mPFS 45.6/9.7mo
👥 @MP_3855 @n8pennell @MNagasaka @EnriquetaFelip Dr. Caicun Zhou
#LCSM @OncoAlert @ros1cancer @ros1dersuk
https://t.co/ta14FkTtbe
📢Replimune's (@Replimune) RP1 (vusolimogene oderparepvec) has received #BLA acceptance & #PriorityReview from the @US_FDA for advanced #melanoma in combination with nivolumab! PDUFA action date is set for July 22, 2025!
FDA grants ODD & RPDD to Medivir’s MIV-711 for LCPD
#medivir #miv-711 #rpdd #lcpd #bone #priorityreview #fda #osteoarthritis #obesity #depression #boneformation #biomarker
@sanofi Reports the US FDA’s Acceptance of sBLA for Dupixent with Priority Review to Treat COPD with Type 2 Inflammation
#sanofi #dupixent #chronicobstructivepulmonarydisease #copd #regulatory #acceptance #sbla #usfda #priorityreview #treatment
https://t.co/KqfYVOG3nr
The MHLW Granted Priority Review to Astellas’ sNDA for Padcev and Keytruda as Combination Therapy to Treat Bladder Cancer
#astellaspharma #padcev #keytruda #bladdercancer #regulatory #priorityreview #mhlw #japan #merck #urothelialcancer #chemotherapy #combinationtherapy #usfda
The US FDA Accepts and Grants Priority Review to BMS’ sNDA for Augtyro to Treat Solid Tumors
#bms #augtyro #solidtumors #regulatory #pi #clinicaltrial #results #safety #efficacy #tolerability #antitumoractivity #adults #pediatricpatients #treatment #acceptance #priorityreview
The #FDA granted #PriorityReview of a supplemental New Drug Application highlighting enzalutamide for the treatment of patients with non-metastatic castration-sensitive #prostatecancer with high-risk biochemical recurrence. https://t.co/cfOZarWvCe
@RGreenSurfsNASH @surfing_NASH $MDGL announces acceptance of the NDA for #Resmetirom. FDA has granted #PriorityReview and assigned a PDUFA date of Mar-14th, 2024.
"The Agency noted that it is not currently planning to hold an advisory committee meeting to discuss the application."
https://t.co/KgJfVPbY2O
. @AstellasUS announces FDA has accepted and granted #PriorityReview of its #zolbetuximab BLA. If approved, it would be the first available in the US for patients with advanced #gastriccancer and #gastroesophagealcancers.
https://t.co/qz95yKXCbV
The @US_FDA has accepted & granted #priorityreview for our LUMISIGHT #NDA & accepted our Lumicell Direct Visualization System #PMA: https://t.co/gGQWnRiaeY. The investigational system allows real-time assessment of the breast cavity for residual #breastcancer detection & removal.
Updates From The Lab 🧪 October 2022
Breaking News 📰 @PharmingGroupNV treatment for APDS, a rare #PrimaryImmunodeficiency, receives #PriorityReview from the #FDA. British Columbia, Canada adds #SCID to their Newborn Screening program.
Learn more at https://t.co/wAtX1HZ1oA
Fantastic news from @PharmingGroupNV! Their #NDA for leniolisib, oral treatment for rare Primary Immunodeficiency APDS, has been accepted by @US_FDA for #PriorityReview. We're thrilled to see the treatment's progress, providing hope to the #APDS community. https://t.co/1o0mxQTvnJ
Gamida Cell announced U.S. FDA accepted with #PriorityReview the Company’s BLA for #omidubicel as a treatment for patients with blood cancers in need of an allogeneic stem cell transplant.
PDUFA date: Jan 30, 2023
Learn More https://t.co/W30rsY0X3z
A positive step to see ALS therapy granted #PriorityReview to expedite #HealthCanada review process. An important step for ALS community who can’t afford to wait but more work to do as Canada still behind as US FDA approved the therapy today. #ALS #AFutureWithoutALS
Today @MTP_CA announced #HealthCanada has accepted its SNDS for oral edaravone under #PriorityReview. We are encouraged by this decision & hopeful it sets an important precedent for all ALS therapies to be granted priority review. Read more: https://t.co/NwGx9NqfB1.
Today @MTP_CA announced #HealthCanada has accepted its SNDS for oral edaravone under #PriorityReview. We are encouraged by this decision & hopeful it sets an important precedent for all ALS therapies to be granted priority review. Read more: https://t.co/NwGx9NqfB1.
Dupixent for Eosinophilic Esophagitis (EoE) Accepted for Priority Review https://t.co/pwxrhugmiu #Dupixent #eosinophilicesophagitis #EoE #priorityreview #medicalresearch @APFEDorg
An important opportunity for the community to have unified, national input in decision-making for ALS therapies. #ALSdefinesunmetneed #ALS #aFutureWithoutALS @ALSCanada #AMX0035 #CADTH @GovCanHealth still has a part to play in granting #PriorityReview #notimetowait
Make your voice heard! @CADTH_ACMTS has posted a call for patient input on AMX0035. We will be preparing a submission reflecting the perspectives of the ALS community & are inviting you to contribute. A survey will launch in early Nov to seek your insights https://t.co/tCygRdMjYq
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