Latest posts tagged with #FDAapproval on Bluesky
Plus Therapeutics Jumps After FDA Grants Orphan-Drug Status: Plus Therapeutics received FDA orphan-drug status on Apr 8, 2026; orphan designation gives 7 years of U.S. exclusivity, changing commercial… 👈 Read full analysis #PlusTherapeutics #OrphanDrug #FDAApproval #HealthcareInvestment #PharmaNews
Mesoblast Gains as FDA Clears Ryoncil Study: FDA cleared Mesoblast study of Ryoncil on Apr 8, 2026; Duchenne affects ~1 in 3,500–5,000 male births and ~15,000–20,000 people in the U.S., creating a… 👈 Read full analysis #Mesoblast #FDAApproval #Ryoncil #DuchenneMuscularDystrophy #ClinicalTrials
Apple's Studio Display XDR now FDA-approved for medical imaging! Radiologists can use the Medical Imaging Calibrator for precise diagnostics. #Apple #StudioDisplayXDR #MedicalImaging #FDAApproval Link: thedailytechfeed.com/apples-studi...
Apple’s Studio Display XDR gets medical imaging clearance from the FDA #Technology #Business #HealthTech #Apple #MedicalImaging #FDAApproval
www.macworld.com/article/3107146/apples-s...
Cocrystal Therapeutics Gets FDA Fast Track: FDA granted Fast Track on Apr 2, 2026 for Cocrystal's norovirus antiviral; CDC estimates 19–21M US cases annually and global burden ~685M (Lancet). 👈 Read full analysis #CocrystalTherapeutics #FastTrack #FDAApproval #Norovirus #Antiviral
Teva Wins FDA Approval for Prolia Biosimilar: Teva secured FDA approval on Mar 30, 2026 for a biosimilar to Amgen's Prolia; 10M Americans have osteoporosis and 1.5M fractures occur annually (CDC). 👈 Read full analysis #Teva #FDAApproval #Prolia #Biosimilar #Osteoporosis
Rocket Pharmaceuticals Rises After KRESLADI Approval: Rocket Pharmaceuticals shares rose 22% on Mar 29, 2026 after FDA approval of KRESLADI; analysts project $250–$450m peak sales and a ~3,200 patient… 👈 Read full analysis #RocketPharmaceuticals #KRESLADI #FDAApproval #Pharmaceuticals #Biotech
🔷 Relacorilant, a selective glucocorticoid receptor antagonist, enhances chemotherapy activity through cortisol pathway modulation, offering a promising new approach for patients with limited therapeutic alternatives.
🔗 Read more: bit.ly/ONCOnews-27M...
#ONCOnews #OncoAlert #OncEd #FDAApproval
Corcept Gains FDA Approval for Cancer Therapy: Corcept received FDA approval on Mar 25, 2026; shares rose ~28% intraday and market cap expanded by ~$600m, accelerating commercial and strategic options for… 👈 Read full analysis #Corcept #FDAApproval #CancerTherapy #PharmaNews #HealthcareInnovation
🔗 Read more: bit.ly/ONCOnews-19M...
#ONCOnews #OncoAlert #OncEd #OvarianCancer #CancerResearch #Oncology #PrecisionMedicine #PersonalizedMedicine #CompanionDiagnostics #Biomarkers #TargetedTherapy #CancerCare #OncologyNews #ClinicalTrials #DrugDevelopment #FDAApproval #PharmaNews #MedTech
#JohnsonandJohnson's much-anticipated oral IL-23 inhibitor, #icotrokinra, has claimed #FDAapproval as a first-line treatment for #plaquepsoriasis.
#GSK is back on level pegging with its rivals in the #respiratorysyncytialvirus (RSV) vaccine category in the #US, after getting #FDAapproval for the 18 to 49 age bracket.
pharmaphorum.com/news/gsks-rs...
🚨 Latest #FDAApproval Update!
🔷 The FDA has approved teclistamab in combination with daratumumab hyaluronidase-fihj for patients with relapsed or refractory multiple myeloma, expanding treatment options in the later-line setting.
Denmark's #AscendisPharma is planning to #launch its once-weekly therapy for a form of #dwarfism in the #US in the second quarter, after securing #FDAapproval for the drug.
Zongertinib Receives FDA Accelerated Approval in HER2-Mutant NSCLC
oncodaily.com/oncolibrary/...
#OncoDaily #Oncology #Cancer #Health #Medicine #NSCLC #MedEd #MedOnc #MedNews #LungCancer #HER2 #TargetedTherapy #FDAApproval
🔷 This first all-oral, fixed-duration (14 cycles), chemo-free regimen reduced progression/death risk by 35% vs.chemoimmunotherapy in the AMPLIFY study (HR 0.65; p=0.0038)
🔗 Read more: bit.ly/ONCOnews23Fe...
#ONCOnews #OncoAlert #OncEd #FDAApproval #CLL #Leukemia #Hematology #Oncology #Cancer
🔷 If approved, giredestrant could offer a targeted endocrine therapy option designed to overcome resistance associated with ESR1 mutations in HR-positive disease.
🔗 Read more: bit.ly/ONCOnews23Fe...
#ONCOnews #OncoAlert #OncEd #FDAApproval #BreastCancer #BreastCancerAwareness #Oncology
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
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🔷 If approved, iberdomide could offer a novel treatment option for heavily pretreated patients with limited therapeutic choices.
🔗 Read more: bit.ly/ONCOnews18Fe...
#ONCOnews #OncoAlert #OncEd #MultipleMyeloma #Hematology #Oncology #CancerResearch #CancerTreatment #FDA #FDAApproval
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
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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
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🔷 Introduces Tumor Treating Fields (TTFields) therapy, a novel, noninvasive, biophysical treatment modality.
🔗 Read more: bit.ly/ONCOnews12Fe...
#ONCOnews #OncoAlert #OncEd #FDAApproval #PancreaticCancer #TumorTreatingFields #Oncology #CancerInnovation #LocallyAdvanced #MedTech #CancerCare
This approval supports biomarker-driven treatment selection and expands access to precision immunotherapy in advanced gynecologic cancers.
🔗 Read more: bit.ly/ONCOnews12Fe...
#ONCOnews #OncoAlert #OncEd #FDAApproval #CompanionDiagnostics #PrecisionOncology #OvarianCancer #GynecologicOncology
age1 leads Series C as Loyal advances LOY-002 toward FDA approval, completing key requirements for conditional approval.
vist.ly/4r96v
#longevity #CanineHealth #VeterinaryMedicine #BiotechFunding #HealthyAging #FDAApproval #PetLongevity #DrugDevelopment
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
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🔷 This update reflects growing evidence supporting CAR T-cell therapy in a high-risk population with limited treatment options, marking a meaningful step forward in CNS lymphoma care.
🔗 Read more: bit.ly/ONCOnews09Fe...
#ONCOnews #OncoAlert #OncEd #FDAApproval #CNSLymphoma #Oncology #Hematology
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
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"Cube Click, Inc. is excited to announce that its flagship medical device, SMILE Dx, has received official approval from the U.S. Food and Drug Administration (FDA)." www.dentistrytoday.com/cube-click-s... #fda #FDAApproval #DentalCare #Dentistry #Dentists #OralHealth #DentalAI #Diagnostics
FDA prior notices shouldn't take hours....automate them with PriorNotify!
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#FDA
#FDAapproval
#priornotice
#PNSI
🚨 Latest #FDAApproval Update!
🔷 FDA grants Fast Track designation to QTX-2101, an investigational oral arsenic trioxide capsule targeting acute promyelocytic leukemia (APL), a rare, rapidly progressive acute myeloid leukemia (AML) subtype with high bleeding risk.
