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Notizia - Recent Pharma, Healthcare and Biotech Happenings

UTR Therapeutics’ UTRxMYCN M1-14 Granted FDA Orphan Drug and Rare Pediatric Disease Designations; Medtronic Announces Regulatory Milestones for New Cardiac Mapping and Ablation Software; Abbott Adds SimpleScreen™ CRC Blood Test to Colorectal Cancer Screening Portfolio; VEMERIX Introduces Patented Single-Use Ultrasound Puncture Kit With Customized Probe Compatibility; Avisi Technologies to Showcase Two-Year VisiPlate® Results at AAO Annual Meeting; FIRE1 Implants First Patient in NORM-HF Pivotal Trial for Innovative Heart Failure Management

UTR Therapeutics Inc. Announced U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for UTRxMYCN M1-14 On 29 September 2026, UTR Therapeutics Inc. announced that the U.S. FDA had granted Orphan Drug Designation to UTRxMYCN M1-14 for the treatment of soft tissue sarcoma, including rhabdomyosarcoma, and Rare Pediatric Disease Designation for rhabdomyosarcoma. The investigational therapy was based on the company’s RNA Overwriting technology, which was designed to target oncogenic messenger RNA associated with MYCN and promote its degradation while preserving healthy messenger RNA. Preclinical studies had demonstrated dose-dependent MYCN in...

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T-Cell Malignancies: The Evolving Treatment Landscape and the Race for Market Leadership

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Empatica Secures FDA Clearance for Parkinson’s Monitoring; ZEISS CLINIC 360 Secures FDA 510(k) Clearance; BioLab Holdings Strengthens Tissue Restoration Portfolio With Addition of FastSkin® Technology; Surity™ Expands Urinary Incontinence Care Portfolio with New At-Home Urinary Management System; Galmed Announces Positive First-in-Human Proof-of-Concept Results for Colospan’s Intraoperative Tissue Assessment Platform; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial

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AstraZeneca Discontinues Phase III eVOLVE-Lung02 Trial of Volrustomig in Metastatic NSCLC; argenx Announces Favorable Topline Results from Phase 3 ALKIVIA Study of Efgartigimod; Bristol Myers Squibb’s ZENBEXUS Receives U.S. FDA Accelerated Approval in Combination with Daratumumab and Dexamethasone for Multiple Myeloma; Zealand Pharma Secures USD 100 Million in Royalty Financing Through Agreement with Royalty Pharma for Rusfertide; PTC Advances Rare Disease Strategy with Acquisition of ST-920 Fabry Disease Program

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Replimune Strengthens Oncology Portfolio With TUDRIQEV Approval

Leica Biosystems Expands Digital Pathology Portfolio with Multiple FDA Clearances; Bracco’s VueJect Ultrasound Contrast Delivery System Gains FDA and Health Canada Authorizations; Oticon Introduces Next-Generation Reveal Hearing Aid With AI; Zepto Life Technology Secures Up to $8.9 Million NIAID Award for Infectious Disease Liquid Biopsy Platform; Nitinotes Broadens EASE IDE Trial Network for EndoZip; FastWave Medical Secures FDA IDE Approval for Pivotal Artero Peripheral IVL Trial

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Sobi Partners with Innate Pharma to License Lacutamab for T-Cell Lymphoma; Yochanra Makes Global Debut in China as First Innovative Drug Designed to Overcome FGFR Inhibitor Resistance; Replimune Secures FDA Accelerated Approval for TUDRIQEV Plus Nivolumab in Advanced Cutaneous Melanoma; FDA Accepts Supplemental Biologics License Application for ENFLONSIA to Broaden RSV Indication in Young Children; Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals

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Rongtao Medical Receives Prestigious Bonded Repair Authorization for Ultrasound in China; NIPRO Introduces ELISIO™-HX Expanded Hemodialysis System to U.S. Market Following FDA Clearance; Lyric Health Unveils Asynchronous Care Solution for Smarter, Connected Virtual Care; New England Biolab® Strengthens Cell-Free RNA Workflow with Monarch® Mag Cell-free RNA Extraction Kit; Aqua Medical Advances Type 2 Diabetes Research with First U.S. Patient Treated at UNC Health; MediView XR90™ Holographic Surgical Navigation System Debuts in Florida at Cleveland Clinic Weston Hospital

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Intratumoral Cancer Therapy: A Potential Weapon To Fight the Battle Against Cancer

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EU Approves Datroway for First-Line Metastatic TNBC; FDA Broadens Pluvicto’s Reach with Approval in PSMA+ mHSPC; AbbVie Announces EU Authorization of RINVOQ for Severe Alopecia Areata; Novo Nordisk Announces Latest Developments from the ZEUS Phase III Trial; Replimune Secures Positive FDA Advisory Committee Vote for RP1 in Advanced Melanoma

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PROTACs: An Emerging Drug Modality with Multiple Oncology Approvals Expected in the Coming Years

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Unlocking New Avenues in KRAS-Driven Cancer Research Beyond G12C

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PD-1 Inhibitors: Which Companies Are Winning the Immunotherapy Race?

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Liquid Biopsy: The Blood Test That Is Redefining Cancer Diagnosis, Monitoring, And Precision Oncology

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The Regenerative Medicine Revolution: Opportunities Shaping the Next Decade

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Sanofi’s SARCLISA ESCENA Makes History as the First Wearable Cancer Treatment

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Top FDA Approvals to Watch in H2 2026: Regulatory Decisions Poised to Transform the Pharmaceutical Landscape

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