Oncology

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Olympus Gains FDA Clearance for EDOF™ Imaging Endoscopes; FDA Approves Abbott’s Tendyne™ Device for Minimally Invasive Mitral Valve Replacement; New Study Validates Exact Sciences’ Oncodetect™ for Enhanced MRD Detection in Stage II-IV Colorectal Cancer; Sensome Completes First-in-Human Trial Enrollment for Lung Cancer Detection System; J&J MedTech Introduces SOUNDSTAR CRYSTAL™ to US Market with Breakthrough 2D Imaging Quality; Terumo Launches ROADSAVER™ Carotid Stent System to Improve Outcomes in Carotid Artery Stenosis

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ADCs in Lung Cancer Treatment: ENHERTU’s Rise, HER3 & TROP-2 Challenges, and What’s Next in the Pipeline

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Artificial Intelligence and Machine Learning in Software as a Medical Device (SaMD)

Abeona Secures FDA Nod for ZEVASKYN, the First Gene Therapy for RDEB; AbbVie Gains FDA Approval for RINVOQ in Giant Cell Arteritis; Lantern Pharma Advances LP-184 with IND Clearance for TNBC Trial; Ichnos Glenmark Earns FDA Fast Track for ISB 2001 in Multiple Myeloma; Rezolute Wins Breakthrough Therapy Designation for Ersodetug in Tumor-Induced Hypoglycemia

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Navigating U.S. Tariffs in 2025: Impacts and Strategies for Pharma and Healthcare

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Boston Scientific Pushes Forward Despite $200M Tariff Challenge; Northstrive Biosciences Gets FDA Green Light to Advance EL-22 Obesity Trial; Roche Acts Swiftly to Offset U.S. Tariff Impact with Global Engagements; Verastem Oncology Secures IND Clearance for KRAS G12D Inhibitor Trial; BlackfinBio Gets FDA OK for Phase I/II Trial of BFB-101 in SPG47

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European Lung Cancer Congress (ELCC) 2025 Recap: Advances in Lung Cancer Research and Treatment

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FDA Approves Sanofi/Regeneron’s DUPIXENT as First New CSU Therapy in Over a Decade; Gilead’s TRODELVY + KEYTRUDA Shows PFS Benefit in PD-L1+ TNBC; Tempest’s TPST-1495 Gets FDA Orphan Tag for FAP; uniQure’s AMT-130 Granted FDA Breakthrough for Huntington’s; NeuroNOS’ BA-102 Secures FDA Orphan Status for Phelan-McDermid Syndrome

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Cellenkos’ CK0801 Granted FDA Orphan Drug Status for Aplastic Anemia; Mirum’s LIVMARLI Gets FDA Nod for Tablet Formulation; SynOx’s Emactuzumab Earns FDA Fast Track for TGCT; Bristol Myers Squibb’s OPDIVO + YERVOY Combo Approved by FDA for First-Line Advanced Liver Cancer; Soleno Launches VYKAT XR, the First FDA-Approved Therapy for PWS-Related Hyperphagia

Feature-AI-Driven Diagnostics_ Why are They the Next Big Thing in Healthcare

AI-Driven Diagnostics: Why are They the Next Big Thing in Healthcare?

Revolutionary Advances and Bright New Horizons in Multiple Myeloma Treatment

Revolutionary Advances and Bright New Horizons in Multiple Myeloma Treatment

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Sanofi’s Qfitlia Becomes First FDA-Approved Therapy for Hemophilia A or B; FDA Approves AstraZeneca’s IMFINZI as First Perioperative Immunotherapy for Bladder Cancer; Beam Therapeutics’ BEAM-302 for AATD Receives FDA Clearance; AstraZeneca’s CALQUENCE Combo Greenlit in EU for Mantle Cell Lymphoma; Ionis’ WAINZUA Wins EU Approval for Hereditary Transthyretin Amyloidosis

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8 Emerging Bispecific Antibodies Transforming NSCLC Treatment

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Alcon Gains CE Mark for Clareon Vivity IOL in Europe; MicroPort MedBot’s Toumai SP Robot Wins NMPA Approval; Abbott Launches Intravascular Lithotripsy Trial; BD Advances GalaFLEX LITE™ Clinical Trial; GE HealthCare Unveils AI-Powered Invenia ABUS Premium; Okami Medical Introduces SENDERO® MAX Catheter

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Illuccix Receives Dutch Approval for PSMA-PET Imaging in Prostate Cancer; FDA Approves Valcare Medical’s Early Feasibility Study for Novel Amend™ Trans-Septal System; RevBio Launches Pivotal Clinical Trial in Europe for Dental Implant Stabilization; Insulet’s RADIANT Trial Highlights Improved Glycemic Outcomes with Omnipod® 5 Following Direct Transition; Envoy Medical Raises $10 Million to Drive Clinical Progress on Next-Gen Hearing Device; Vave Health Unveils World’s First Wireless Whole-Body Ultrasound with Single PZT Transducer

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Neurotech’s ENCELTO Becomes First FDA-Approved Treatment for MacTel Type 2; Plus Therapeutics’ Rhenium Obisbemeda Gets FDA Orphan Status; Novo Nordisk Cuts WEGOVY to $499/Month; Capricor’s Deramiocel Wins FDA Priority Review; Celltrion’s OMLYCLO Becomes First Interchangeable XOLAIR Biosimilar

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TEVIMBRA’s Winning Streak — BeiGene Secures New Indication for PD-1 Drug

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