#fdaapproval search results
FDA Approval Alert! Belantamab mafodotin returns stronger than ever — a BCMA ADC redefining survival in relapsed myeloma. 31 mo PFS, OS HR 0.49 — DREAMM-7 sets a new benchmark. #FDAapproval #MultipleMyeloma #Blenrep #Oncology #Hematology #ADC #CancerResearch #DREAMM7…
The FDA has approved fosfomycin to treat complicated urinary tract infections in adults. The antibiotic showed strong efficacy and safety, offering a new option against drug-resistant bacteria. #UTI #Antibiotics #FDAApproval Read more: contemporaryobgyn.net/view/fda-appro…
#FDAApproval: The @US_FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma #mmsm Approval based on findings from the phase III AQUILA trial 🔗ascopost.com/news/november-…
FDA approves elinzanetant (Lynkuet), the first nonhormonal therapy targeting NK1 and NK3 pathways for menopausal hot flashes. Phase 3 data show significant symptom reduction and strong tolerability. Details 👉ow.ly/zRx550XikJM #Menopause #FDAApproval #HotFlashes
🚨 The @US_FDA has approved belantamab mafodotin-blmf (Blenrep)+bortezomib and dexamethasone for adults with relapsed/refractory multiple myeloma after ≥2 prior lines of therapy, including a proteasome inhibitor and an IMiD #MultipleMyeloma #FDAApproval ascopost.com/news/october-2…
🚨 #FDA approves subcutaneous pembrolizumab (Keytruda Qlex). PK comparability met; ORR 45% SC vs 42% IV in MK-3475A-D77 trial ~1–2 min admin—logistics win, efficacy preserved. #FDAApproval #Oncology #Immunotherapy #CancerResearch #NSCLC #Keytruda #Subcutaneous
The FDA has approved Imlunestrant for ER+, HER2-negative breast cancer. This Breast Cancer Awareness Month, we celebrate new treatment options that bring hope. How do you see therapies like Imlunestrant changing care? #BreastCancerAwarenessMonth #FDAApproval #Oncology
📢Darolutamide FDA-approved for de novo mCSPC Prostate Cancer on 6/3/25! ✅10-yr timeline: 2015 (Docetaxel HR 0.73) → 2025 (Darolutamide OS HR 0.81). 📉rPFS HR 0.54. Trial populations matter! 📰In-Depth Article: oncologytube.com/darolutamide-f… #mCSPC #FDAApproval #OncoTwitter…
🌟🇺🇸 #FDAApproval Alert🚨 📅 Aug 6, 2025 ➡️ The FDA has granted accelerated approval to dordaviprone (Modeyso) for H3 K27M-mutant diffuse midline glioma in pts ≥1 y/o with progression after prior therapy. This is the first systemic therapy approved for this indication. 🔬 🧪…
The CGuard® Prime Carotid Stent System is now FDA approved! Hear from Marvin Slosman, CEO of InspireMD, as he shares a special announcement on this major milestone—the next generation of carotid artery stenting has officially arrived in the U.S. #FDAApproval #CGuardPrime
FDA Accelerates PORT-77 for Rare Sunlight-Sensitive Disorders bit.ly/47cwboR Read now at PatientWorthy.com #PatientWorthy #FDAApproval #XLP #EPP #Sunlight-SensitiveDisorders
🚨 FDA approves Zepzelca (lurbinectedin) in combination with Tecentriq or Tecentriq Hybreza for maintenance treatment of extensive-stage SCLC after first-line therapy clinicaloncology.com/a/fzIBAA/t #SCLC #LungCancer #FDAApproval
The FDA has approved the Insti HIV Self Test, making it the first #HIV self-test in the United States capable of delivering results in just one minute. #FDAapproval #pharmacy Read More: hubs.li/Q03P5Plm0
The @US_FDA has approved lurbinectedin + atezolizumab OR atezolizumab + hyaluronidase-tqjs as maintenance for adults with ES-SCLC without progression on first-line atezolizumab ± hyaluronidase-tqjs, carboplatin, etoposide #FDAApproval #SCLC ascopost.com/news/october-2…
New FDA approval: Subcutaneous Keytruda Qlex now available for solid tumors. Expect shorter infusion times, fewer central lines, and streamlined care. What to know: bit.ly/4gKEPxV #FDAApproval #OncologyNews #SolidTumors
🚨 The @US_FDA has approved revumenib (Revuforj) for R/R #AML with susceptible NPM1 mutation in adult & pediatric patients ≥1yr without alternative treatment options Supportive data from AUGMENT-101 trial show CR+CRh rate of 23.1% #FDAApproval ascopost.com/news/october-2…
The @US_FDA approved estrogen receptor antagonist imlunestrant for pts with ER+/HER2– ESR1-mutant advanced/metastatic breast cancer with disease progression after ≥1 endocrine therapy ➡️Companion diagnostic also approved ascopost.com/news/september… #BCSM #BreastCancer #FDAApproval
LUPIN LIMITED – US FDA APPROVAL ✅ Received approval for Lenalidomide Capsules (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg & 25 mg), bioequivalent to Revlimid, a key oncology drug ▶️ Estimated annual U.S. sales: USD 7,511 million (IQVIA MAT July 2025) #LUPIN #FDAApproval #Lenalidomide…
BREAKING: The FDA approved VYKAT XR (formerly DCCR) as the first-ever treatment for hyperphagia in PWS! A huge win for our community! Learn more: bit.ly/3DWLhTB Press release: bit.ly/426KZSf Stay tuned for details, April 16 webinar. #PWSCommunity #FDAApproval
U.S. FDA approves KYGEVVI (doxecitine and doxribtimine), the first and only treatment for adults and children living with thymidine kinase 2 deficiency (TK2d) stellanews.life/technology_cat… #FDAapproval #RareDisease #TK2d #UCB #MitochondrialDisorders #OrphanDrug #BreakthroughTherapy…
#FDAApproval: The @US_FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma #mmsm Approval based on findings from the phase III AQUILA trial 🔗ascopost.com/news/november-…
🚨#FDAApproval alert! 📢 FDA approves Daratumumab and Hyaluronidase-fihj (Darzalex Faspro®, Janssen Biotech, Inc.) for patients with high-risk smoldering multiple myeloma. 🧬 Approval based on the AQUILA trial with 390 patients — showing strong efficacy as monotherapy vs active…
The FDA has Issued a Complete Response Letter to Xspray Pharma Delaying Approvals Affecting ALL and CML bit.ly/4hArZ5U Read now at PatientWorhty.com #PatientWorthy #FDAApproval #ALL #CML #Ph-CML
FDA approves JNJ’s CAPLYTA for depression: Is this a new hope for MDD remission? business-news-today.com/fda-approves-j… #FDAApproval #MentalHealthMatters #CAPLYTA #MajorDepressiveDisorder #DepressionRelief #Neuropsychiatry #PharmaNews #JohnsonAndJohnson #PsychiatryUpdate #BipolarDisorder…
#Leukemia #CancerResearch #FDAApproval #ClinicalTrials #MSKResearch #CancerTreatment #PediatricOncology #NPM1 #KMT2A #PrecisionMedicine #Revumenib #Revuforj #LeukemiaAwareness #MSKNews
UPDATE: Based on a clinical trial led by @Doctor_E_Stein, Chief of the Leukemia Service at MSK, the @FDA has approved revumenib (Revuforj®) for patients 1-year-old and older who have #leukemia that has come back after treatment and whose cancer carries molecular changes called…
A significant breakthrough for the rare disease community. The U.S. FDA has approved KYGEVVI® (doxecitine and doxribtimine), developed by UCB, Read more about this milestone: buff.ly/WvqooJm #FDAApproval #Biotech #RareDisease #MitochondrialDisease #TK2d #Kygevvi #UCB
Big news 💥 $IRWD just made history! The FDA approves the first-ever drug for kids 7+ battling irritable bowel syndrome with constipation 😲 This changes everything for families and the medical world! #IRWD #FDAApproval #PediatricHealth #IBS #ChronicIllness #MedicalBreakthrough…
US FDA Approves First Oral Diabetes Drug to Prevent Heart Attacks and Strokes For more details : tinyurl.com/ys9s43n5 #Rybelsus #FDAApproval #Type2Diabetes #HeartHealth #DiabetesCare #Semaglutide #BloodSugarControl #WeightManagement #PharmaNews #HealthyHeart #InsightsCare
The FDA has approved fosfomycin to treat complicated urinary tract infections in adults. The antibiotic showed strong efficacy and safety, offering a new option against drug-resistant bacteria. #UTI #Antibiotics #FDAApproval Read more: contemporaryobgyn.net/view/fda-appro…
Pulsenmore Receives FDA Clearance for At-Home Prenatal Ultrasound #fda #fdaapproval #ultrasound 2digital.news/pulsenmore-rec…
🍀✨️FDA SHIFTS STANCE ON $QURE: The FDA disagreed with uniQure's data for its Huntington's gene therapy (AMT-130) after a pre-BLA meeting. $QURE stock is plunging on the news. (Source: Benzinga) 📉🧬 #FDAApproval #BiotechNews #QURE #REALCULTNEWS
FDA Approval Alert! Belantamab mafodotin returns stronger than ever — a BCMA ADC redefining survival in relapsed myeloma. 31 mo PFS, OS HR 0.49 — DREAMM-7 sets a new benchmark. #FDAapproval #MultipleMyeloma #Blenrep #Oncology #Hematology #ADC #CancerResearch #DREAMM7…
🚨 #FDA approves subcutaneous pembrolizumab (Keytruda Qlex). PK comparability met; ORR 45% SC vs 42% IV in MK-3475A-D77 trial ~1–2 min admin—logistics win, efficacy preserved. #FDAApproval #Oncology #Immunotherapy #CancerResearch #NSCLC #Keytruda #Subcutaneous
Biocon Biologics Gets US FDA Approval for Insulin Aspart 'Kirsty' #BioconBiologics #Kirsty #FDAApproval #InsulinBiosimilar #DiabetesCare #AffordableInsulin #Biosimilars #NovoLogAlternative
The FDA has approved fosfomycin to treat complicated urinary tract infections in adults. The antibiotic showed strong efficacy and safety, offering a new option against drug-resistant bacteria. #UTI #Antibiotics #FDAApproval Read more: contemporaryobgyn.net/view/fda-appro…
FDA approves elinzanetant (Lynkuet), the first nonhormonal therapy targeting NK1 and NK3 pathways for menopausal hot flashes. Phase 3 data show significant symptom reduction and strong tolerability. Details 👉ow.ly/zRx550XikJM #Menopause #FDAApproval #HotFlashes
Florida’s rethinking school lunches 🍎 New UTI antibiotic 💊 Alzheimer’s blood test 🧠 Microplastics in gum 😬 And yep, another pig kidney transplant 🐷 Full breakdown in our latest episode 🎧 #MedicalNews #FDAApproval #SchoolNutrition #Alzheimers #UTI #PublicHealth
🌟🇺🇸 #FDAApproval Alert🚨 📅 Aug 6, 2025 ➡️ The FDA has granted accelerated approval to dordaviprone (Modeyso) for H3 K27M-mutant diffuse midline glioma in pts ≥1 y/o with progression after prior therapy. This is the first systemic therapy approved for this indication. 🔬 🧪…
New study by @rne_md @UCSD_ObGyn reinforces prior findings that resulted in #FDAApproval of a new standard of care treatment option in #EndometrialCarcinoma highlighting the clinical benefit of chemotherapy + #pembrolizumab in patients... Discover study ⬇️ go.ucsd.edu/422V83j
FDA approval of Taletrectinib for ROS1 positive Non Small Cell Lung Cancer @FDAOncology @US_FDA oncodaily.com/opinion/311850 #FDAApproval #NSCLC #OncoDaily #Oncology #ROS1positive #Taletrectinib #Medicine #Health #MedEd #MedX
🚨 The @US_FDA has approved belantamab mafodotin-blmf (Blenrep)+bortezomib and dexamethasone for adults with relapsed/refractory multiple myeloma after ≥2 prior lines of therapy, including a proteasome inhibitor and an IMiD #MultipleMyeloma #FDAApproval ascopost.com/news/october-2…
🚨 FDA approves Zepzelca (lurbinectedin) in combination with Tecentriq or Tecentriq Hybreza for maintenance treatment of extensive-stage SCLC after first-line therapy clinicaloncology.com/a/fzIBAA/t #SCLC #LungCancer #FDAApproval
#FDAApproval: The @US_FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma #mmsm Approval based on findings from the phase III AQUILA trial 🔗ascopost.com/news/november-…
‼️ Big news in the world of breast reconstruction: The FDA has approved Mentor MemoryGel Enhance implants, offering sizes from 930 cc to 1445 cc ‼️ Here’s what this means for breast cancer survivors. 🧵👇 #BreastReconstruction #FDAApproval
FDA Approves First Pig Kidney Transplant Trials, Offering Hope for Organ Shortage. #KidneyTransplant #OrganShortage #FDAApproval #MedicalInnovation #Xenotransplantation
New FDA approval: Subcutaneous Keytruda Qlex now available for solid tumors. Expect shorter infusion times, fewer central lines, and streamlined care. What to know: bit.ly/4gKEPxV #FDAApproval #OncologyNews #SolidTumors
Elon Musk's Neuralink gets FDA approval for its 'Blindsight' device, which could restore vision to those who’ve lost both eyes and optic nerves or even those blind from birth if their visual cortex is intact. #Neuralink #FDAApproval #Innovation #FutureOfSight #Tech #ElonMusk
Exciting news! FDA approves Zolbetuximab for advanced gastric/GEJ cancer. SPOTLIGHT & GLOW trials show ✅median OS: 16.4 months ✅median PFS: 9.2 months. A game-changer for patients!** 🧬📊 #Oncology #FDAApproval #CancerResearch
🚨 Big news for the PKU community! @FDA has approved Sephience™ (sepiapterin) by @PTCBio — a new treatment option for both children and adults living with Phenylketonuria. Hope just got a major boost! 💊💙 #PKU #FDAApproval #RareDisease prnewswire.com/news-releases/…
The @US_FDA has approved cemiplimab-rwlc for the adjuvant treatment of adults with cutaneous squamous cell carcinoma #skincancer #FDAApproval based on findings from the C-POST study - Median DFS not reached vs 49.4 months w/ placebo (HR = 0.32; P < .0001) ascopost.com/news/october-2…
The @US_FDA has approved lurbinectedin + atezolizumab OR atezolizumab + hyaluronidase-tqjs as maintenance for adults with ES-SCLC without progression on first-line atezolizumab ± hyaluronidase-tqjs, carboplatin, etoposide #FDAApproval #SCLC ascopost.com/news/october-2…
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