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Genito Urinary System and Sex Hormones

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

AUCATZYL Approved for R/R B-ALL; FDA Accepts NDA for Unicycive’s Oxylanthanum Carbonate; AstraZeneca and Amgen Report Positive Results in Chronic Rhinosinusitis; Nipocalimab Granted Breakthrough Designation for Sjögren’s Disease; AbbVie’s Schizophrenia Drug Fails Phase Studies

FDA Approves Autolus's AUCATZYL for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia Autolus Therapeutics has achieved a significant milestone with FDA approval for AUCATZYL (obecabtagene autoleucel), a next-generation CAR T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). This approval, granted based on results from the FELIX clinical trial, highlights the therapy's efficacy, with a 63% overall complete remission rate in the efficacy-evaluable patient cohort. Notably, AUCATZYL also demonstrated a favorable safety profile with low rates of severe Cytokine Release Syndrome and Immune Effector Cell-Associated...

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Travere’s FILSPARI Approval Sparks Rivalry in the IgA Nephropathy Space

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Novartis’ FABHALTA: Leading the Way as the First Complement Inhibitor for IgAN

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Masimo W1® Medical Watch Secured FDA 510(K) Clearance; Stereotaxis Received the CE Mark in Europe and Submitted a 510(K) Application in the US; Replimune Dosed First Patient in the IGNYTE-3 Clinical Trial; Daré Bioscience Announced the Publication of Positive Findings From the Phase IIb RESPOND Clinical Study; Baxter’s Definitive Agreement to Carlyle For USD 3.8 Billion; Moximed Successfully Closed a USD 91 Million Series D Financing Round

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STRATA Skin Sciences’ XTRAC Momentum™ 1.0 Device Approved in Japan; eCential Robotics Received FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device; MicroVention Announced the Results of the Clinical Evaluation of WEB™ 17 Device; Neuspera Medical, Inc.’s SANS-UUI Pivotal Clinical Trial; GE HealthCare Announced an Agreement to Acquire the Clinical Artificial Intelligence Business; Sutter Health Implemented World’s First Wearable Doppler Ultrasound Patch

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4 Late-Stage IgA Nephropathy Treatment Drugs to Look Out

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AstraZeneca’s Voydeya FDA Approval; Akebia’s Vafseo FDA Approval; Bristol Myers Squibb’s Phase III YELLOWSTONE Trial Update; Astellas’ IZERVAY FDA Approval; AstraZeneca’s Truqap and Faslodex MHLW Approval

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Promising Nephrotic Syndrome Treatments: A Look into the Future

Hormone Replacement Therapy Market Analysis

Hormone Replacement Therapy Market: Unveiling the Growth Opportunities and Key Players Exploring the Domain

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Advancements in Complement 3 Glomerulopathy (C3G) Treatment: Exploring Upcoming Anti-Complements

MedTech News for ResMed, Masimo, Viz.Ai, UroMems

Tandem’s Automated Insulin Patch Pump; ResMed’s Bilevel Sleep Respiratory Devices; Masimo’s First Over-The-Counter Fingertip Pulse Oximeter; Viz.Ai Algorithm for Quantifying Intracerebral Hemorrhage; Canary Medical’s Heart Sound Monitor; UroMems’ Smart Urinary Sphincter System

MedTech News for Samsung, BIOCORP, CroiValve, FastWave Medical

Samsung Partnered with Lunit; Boston Scientific Launched VersaVue single-use Flexible Cystoscope; Element Science’s Patch-wearable Cardioverter Defibrillator; BIOCORP Received 510(k) FDA Clearance for SoloSmart; FDA IDE for CroiValve’s Tricuspid Heart Valve; FastWave Medical’s First-in-human Study of its IVL Tech

A Glance at Key Insights From 42nd J.P. Morgan Annual Healthcare Conclave

MedTech News for Medtronic, Cala, Medline, Rivermark Medical

Medtronic Announced World’s First Approval for MiniMed 780G System; CE Mark for Medtronic’s Next Generation Micra Leadless Pacing Systems; Biosense Webster Received Approval for VARIPULSE PFA Platform; Rivermark Medical Updated on Flostent System; Cala Disclosed TAPS Therapy Data for Essential Tremor; Medline Introduced Transparent Wound Dressing

MedTech News for BrainSpec, Revvity, FormaPath, Pramand

Baird Medical’s Microwave Ablation System; BrainSpec’s AI-Backed Solution for Non-Invasive Brain Chemistry Measurement; AWAK’s AI-Enabled Kidney Disease Prediction Tool; Revvity’s EONIS Q System; FormaPath Announced Advancement in Cancer Pathology; Pramand Launched CraniSeal Dural Sealant

MedTech News for Samsung, Lunit, Vivasure

GE Healthcare and Masimo Announced Collaboration; Samsung Launched New Ultrasound System ‘V6’; MONARCH Platform Approved for Bronchoscopy in China; Lunit Received FDA Nod for Lunit INSIGHT DBT; Route 92 Medical Releases Tenzing Technology Clinical Findings; Vivasure Medical Enrolled 100th Patient for its Vivasure PerQseal Closure Device System Study

Pharma News for Bayer, Merck, Ayala, GARDP, AstraZeneca

New Asundexian Phase III Study Result; Zibotentan/Dapagliflozin Combination Demonstrated Significant Albuminuria Reduction Chronic Kidney Disease; Orphan Drug Designation to Rhenium Obisbemeda; FDA Approves Merck’s KEYTRUDA Plus Gemcitabine and Cisplatin for Biliary Tract Cancer; Orphan Drug Designation to Ayala’s AL102; GARDP Announces Successful Phase 3 Trial of of Uncomplicated Gonorrhea

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