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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Roche Receives FDA Approval for Itovebi; FDA Approves Bausch + Lomb’s Envista® Envy™; Microbot Medical Successfully Completes Pivotal Human Clinical Trial and Accelerates Go-to-Market Strategy for LIBERTY® Launch; Positive FDA Guidance on Phase III Trial of 64Cu-SAR-Bispsma for Recurrent Prostate Cancer; ELEHEAR Launches Hearing Aids at Just $399; Abbott Advances Pulsed Field Ablation Studies and Launches New Technology for Cardiac Mapping

FDA Approved Roche’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation On October 11, 2024, Roche announced that the United States Food and Drug Administration (FDA) approved Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence after completing adjuvant endocrine therapy. The PIK3CA mutation ...

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Vivos Therapeutics Receives FDA 510(k) Clearance for Pediatric Sleep Apnea; Nevro Launches AI-Driven Spinal Cord Stimulation; Jupiter Endovascular Treated First Patients in Pulmonary Embolectomy System Study; Toro Neurovascular Advances Stroke Treatment with SuperBore Aspiration Catheter; GE HealthCare Introduces Venue Ultrasound Solutions; Linear Health Expands Orchid Safety Valve Indications

Duchenne Muscular Dystrophy Market

Duchenne Muscular Dystrophy Market: What’s More Beyond Exon-Skipping Therapies?

4-late-stage-thyroid-eye-disease-treatments

Late-Stage Thyroid Eye Disease Treatments: 4 Prominent Therapies to Consider

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Top 8 Breakthrough Gene Therapies for Retinitis Pigmentosa Treatment

pharma-news-for-eli-lilly-ideaya-roche-sanofi

Lilly’s Morphic Acquisition; IDEAYA’s IDE397 Positive Phase II Trial Result; XPOVIO (selinexor) Approval in China; Roche to Reintroduce Susvimo in the US; Dupixent EU Approval

medtech-news-for-alcon-globus-medical-ricoh-esaote

Alcon’s 510(k) Clearance From the FDA; Globus Medical Received FDA Clearance; UK Pioneers First Skull-Mounted Epilepsy Device for Child; The Initiation of a Significant Clinical Trial of 3d Printed Models; Esaote Unveiled the Cutting-Edge Mylab™E80 @Sirm Ultrasound Device For 2024; Medasense Unveiled a Transformative Partnership With Nihon Kohden Corporation

opportunities-in-dry-amd-treatment

Dry AMD Treatment- An Underserved Market With Billion-Dollar Potential

medtech-news-for-stryker-qiagen-evolution-optiks-nexalin

Stryker’s LIFEPAK 35 Monitor/Defibrillator; Qiagen’s QIAstat-Dx Respiratory Panel; Evolution Optiks’s 510(k) Clearance; Microbot Medical Endovascular Surgical Robot Trial; Nexalin’s Insomnia and Anxiety Therapy Headset Clinical Trial; KORU Medical Systems’ Study With Commercialized Oncology Biologics

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Boehringer Ingelheim’s Diabetic Macular Ischemia Study; Novartis’ Mariana Oncology Acquisition; Astellas and Poseida Therapeutics Partnership; Prime Medicine’s PM359 IND; Pfizer’s TIVDAK FDA Approval

unmet-needs-in-glaucoma-treatment

The Unmet Needs in Glaucoma Treatment: Bridging Gaps for Better Vision Care

medtech-news-for-carl-zeiss-abbott-medtronic-edwards

Carl Zeiss Meditec AG’s Acquisition of Dutch Ophthalmic Research Center; Johnson & Johnson’s Shockwave Medical Acquisition; Biora Therapeutics’ BT-600 Positive Results; Medtronic’s Single-Shot Mapping Ablation Catheter Positive Data; Abbott’s TriClip FDA Approval; Abbott’s Whole Blood Rapid Test FDA Clearance

pharma-news-for-bms-astrazeneca-astellas-akebia

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

medtech-news-for-tela-bio-stryker-livanova-c2dx

TELA Bio Launched Hernia Mesh Fixation Devices; Stryker Acquisition of SERF SAS; FDA 510(k) Clearance for RedDrop Dx’s Blood Collection Device; FDA 510(k) Clearance for Next Generation Shaw Scalpel; LivaNova’s Sleep Apnoea Device Trial; Nanodropper’s Positive Impact on Glaucoma Treatment

medtech-news-for-vygon-butterfly-network-cosm-medical

Vygon Launched Nutrisafe2 System; Butterfly Network Launched Third-Gen Ultrasound; Cosm Medical Won FDA Clearance; FDA Cleared Sequel Med Tech Automated Insulin Delivery System; IceCure Medical Reported Positive Topline Results; Cerus Announced Positive Results in Blood Purification Trial

gene-therapies-in-ophthalmology

Gene Therapies as a Game-Changer in Ophthalmology: Eyeing the Future

MedTech News for X-trodes, Lumicell, Konesksa

Johnson & Johnson’s Tecnis PureSee lens; Sparrow BioAcoustics’s Stethoscope Software; Better Therapeutics’s MASH Treatment; X-trodes’ Wearable “Skin” Solution; Lumicell’s LUMISIGHTTM; Konesksa Enrolled First Patient in Learns Observational Study

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