VativoRx, LLC

🚨 FDA approves Ryoncil® (remestemcel-L-rknd) for treating steroid-refractory acute GVHD in pediatric patients 2+ months old. A pioneering MSC therapy, Ryoncil offers a new hope for children with this life-threatening condition. 🏥 Launch details are pending. https://lnkd.in/eZFRBZWK #HealthNews #FDAApproval

FDA approves Unloxcyt™ (cosibelimab-ipdl) for adults with advanced cutaneous squamous cell carcinoma who can't undergo surgery or radiation. A first-in-class PD-L1 inhibitor, it's given every 3 weeks via IV. Launch date & pricing TBD. More info: https://lnkd.in/e8DUXkAp #cSCC #CancerTreatment

🎉 FDA approves Crenessity™ (crinecerfont) by Neurocrine Biosciences for classic congenital adrenal hyperplasia (CAH) to manage androgen levels in adults & kids over 4. First-in-class CRF1 antagonist, expected to hit the market next week. More on dosing & availability soon. https://lnkd.in/eu5uZ8Uf #HealthNews

🚨 The FDA has approved Yesintek™ (ustekinumab-kfce) by Biocon Biologics, a biosimilar to Stelara®. Targeting IL-12 & IL-23, it's set to treat Crohn’s, ulcerative colitis, psoriasis, & psoriatic arthritis. Launch date: no later than Feb 22, 2025. https://lnkd.in/e5irfTG2 #Healthcare #Biosimilar

🚨 FDA grants accelerated approval to Bizengri® (zenocutuzumab-zbco) for NSCLC & pancreatic cancer with NRG1 gene fusions. This first-of-its-kind bispecific antibody targets HER2 & HER3 receptors, offering new hope to patients with advanced cancers. Launch info coming soon! More Information here: https://lnkd.in/er9e84rq #CancerTreatment #Bizengri

🚨 FDA approves Imkeldi® (imatinib) oral solution for treating CML, ALL, GIST, and MDS/MPD. This new strawberry-flavored formula provides a versatile option in cancer treatment. Details on pricing & availability are coming soon. More Details: https://lnkd.in/ef6gbb4N #CancerCare #Imkeldi

🎉 FDA greenlights Attruby™ (acoramidis) for treating transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM). This oral treatment aims to reduce cardiovascular death & hospitalization. Expected launch soon with an annual cost of $244K. More details on its promising impact! https://lnkd.in/esKEc3s3 #HeartHealth #ATTRCM

🚨 #FDA approves Bimzelx® (bimekizumab-bkzx) for moderate-to-severe hidradenitis suppurative (HS), its fifth indication. Key trials show significant symptom reduction in HS patients. Bimzelx targets IL-17A and IL-17F, improving patient outcomes. https://lnkd.in/eukRgtXa #Dermatology #HidradenitisSuppurativa

🚨 FDA approves Ziihera® (zanidatamab-hrii) for HER2+ biliary tract cancer (BTC) in adults with prior treatment. First HER2-targeted therapy for BTC, showing 52% response rate! Launch info coming Dec. 11. https://lnkd.in/e2i_KC7N #BiliaryCancer #FDAApproval #Ziihera

🚀 Breakthrough in leukemia treatment! #FDA approves Syndax Pharmaceuticals' Revuforj® (revumenib), the first menin inhibitor for R/R acute leukemia with KMT2A translocation in adults & children aged 1+. Launch this Nov. with a $474K annual cost. https://lnkd.in/e7N9yFnV #LeukemiaTreatment #Revuforj