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Notizia - Recent Pharma, Healthcare and Biotech Happenings

pharma-news-for-agios-bridgebio-rigel

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Agios’ PYRUKYND SNDA Accepted by FDA for Thalassemia; BridgeBio’s BBO-8520 Gets FDA Fast Track for KRASG12C-Mutated Lung Cancer; Nipocalimab Granted FDA Priority Review for Myasthenia Gravis; Rigel’s R289 Receives FDA Orphan Drug Designation for MDS; Rise Therapeutics Gets FDA IND Clearance for R-5780 in Cancer

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medtech-news-of-roche-nanovibronix-hologic

Roche Secures FDA Clearance for High-Volume Slide Scanner; Pacira Gets 510(k) Approval for Iovera° SmartTip for Chronic Back Pain; ClearCut Presents Clearcoast™ Study Results at San Antonio Breast Cancer Symposium; NanoVibronix Completes UroShield® Pilot Study at University of Michigan; Hologic Finalizes Acquisition of Gynesonics; Movano Health Launches EvieAI Virtual Wellness Assistant.

pharma-news-for-chimerix-verastem-capricor

Chimerix Submits Dordaviprone NDA for Accelerated Approval in Recurrent H3 K27M-Mutant Diffuse Glioma to FDA; NMD Pharma’s NMD670 Receives FDA Orphan Drug Designation for Charcot-Marie-Tooth Disease; Verastem’s Avutometinib NDA Accepted for KRAS Mutant Ovarian Cancer; Capricor Submits BLA for Deramiocel in Duchenne Muscular Dystrophy; Axsome Completes Phase III Trial of AXS-05 for Alzheimer’s Agitation

medtech-news-for-inogen-microtech-innovent

Genesis Medtech Secures Chinese Approval for Innovative 90° Articulating Stapler; Inogen Secures FDA 510(k) Clearance for SIMEOX 200 Airway Clearance Device; Microtech Unveils First Human Trial of Implantable Microsensor for Heart Failure Monitoring; NAVIGANTIS VASCO™ Platform Begins Clinical Role in Neurovascular Patient Study; Innovent Secures Global Rights from Roche for Novel DLL3 ADC in Exclusive Deal; Treace Expands Portfolio with Percuplasty

pharma-news-for-precigen-bms-sapience

FDA Approves Opdivo Qvantig™ for Solid Tumors; Nuvation Bio’s Taletrectinib NDA Accepted for ROS1-Positive NSCLC; HKBU’s Aptamer for X-Linked Hypophosphatemia Gets FDA Orphan Designation; Sapience’s ST316 Receives FDA Orphan Status for FAP; Precigen Submits BLA for PRGN-2012 in RRP

medtech-news-for-merit-medical-avita-medical-seastar-medical

FDA Grants Approval to Merit Medical’s WRAPSODY Endoprosthesis; FDA Clears AVITA Medical’s Cohealyx, Expanding Treatment Potential; SeaStar Medical Launches 14th Location for Adult AKI Pivotal Study; Contego Medical’s Neuroguard IEP System Treats First Patients; SMT Introduces Hydra™ TAVI System in Russia; SandboxAQ Raises $300M+ to Accelerate AI’s Next Frontier

pharma-news-for-vertex-tonix-quoin

FDA Approves Vertex’s ALYFTREK for Cystic Fibrosis; ZEPBOUND Gets FDA Approval for Obstructive Sleep Apnea in Obese Adults; Tonix’s TNX-102 SL NDA Accepted for Fibromyalgia; Quoin’s QRX003 Clears FDA for Netherton Syndrome Study; FDA Approves First Mesenchymal Stromal Cell Therapy for Acute GvHD

medtech-news-for-siemens-medtronic-jnj

Siemens Healthineers Acquires Molecular Imaging Division from Novartis; BD and Babson Diagnostics Unveil Fingertip Blood Testing for Health Care; Medtronic Completes First Ingestion of Pillcam™ Genius SB Kit; FDA Expands Impella Heart Pump Use to Pediatric Patients; Zimmer Biomet Receives FDA Nod for OsseoFit™ Stemless System; enVVeno Medical Completes Final Implants in Pre-Clinical GLP Study

pharma-news-for-neurocrine-checkpoint-maia

FDA Approves Neurocrine’s CRENESSITY for Congenital Adrenal Hyperplasia; Checkpoint’s UNLOXCYT Approved; MAIA’s THIO Gets Rare Pediatric Disease Designation; JEMPERLI  Receives Breakthrough Therapy for Rectal Cancer; Galderma’s NEMLUVIO Approved for Atopic Dermatitis.

medtech-news-for-angiodynamics-zynex-cota

Stereotaxis and Shanghai MicroPort EP Medtech Co., Ltd. Receives Approval for Magbot Robotic Magnetic Navigation Ablation Catheter From China’s NMPA; AngioDynamics NanoKnife® System Approved by FDA for Prostate Tissue Treatment; Zynex Successfully Completes Laser Pulse Oximetry Clinical Trial; COTA, PreciseDx, and Baptist Health Validate AI-Powered PreciseBreast as Equivalent to Oncotype DX; Medtronic Introduces Percept™ RC Rechargeable Neurostimulator; Crown Aesthetics Raises the Bar with the Introduction of SkinPen® Precision Elite

pharma-news-for-abbvie-gsk-novartis

AbbVie Reveals Phase III TEMPO-2 Trial Positive Topline Results; FDA Accepts GSK’s NUCALA Submission in COPD; Novartis Boosts Huntington’s Disease Development Program with PTC518 In-Licensing; Chimerix to File for Accelerated FDA Approval of Dordaviprone for H3 K27M-Mutant Diffuse Glioma; MeiraGTx Receives FDA RMAT Designation for AAV2-hAQP1 in Grade 2/3 Radiation-Induced Xerostomia Treatment

medtech-news-for-zimmer-biomet-orthocell-hologic

FDA Approves Zimmer Biomet’s Oxford® Cementless Partial Knee; ReCerf® Sets Milestone as First All-Ceramic Hip Resurfacing Approved Worldwide; Orthocell Achieves US FDA 510(k) Clearance Milestone for Remplir Regulatory Study; Hologic’s Research Shows AI Breast Imaging Maintains Performance Across All Demographics; GE HealthCare Expands MRI Capabilities with Sonic DL’s Advanced Deep Learning; Terumo Unveils the R2P NaviCross Peripheral Support Catheter

pharma-news-for-applied-therapeutics-alnylam-rigel

FDA Grants Fast Track for Lin BioScience’s LBS-007; Alnylam’s AMVUTTRA sNDA Under Review; FDA Approves RAPIBLYK for Atrial Fibrillation; Applied Therapeutics Receives CRL for Govorestat in Galactosemia; R289 Gets Fast Track for Lower-Risk MDS.

medtech-news-for-medtronic-zimmer-biomet-abbott

FDA Clears Medtronic’s New Inpen™ App; Zimmer Biomet Gets FDA Approval for Oxford® Cementless Partial Knee; Perimeter B-Series OCT with ImgAssist AI 2.0 Shows Significant Superiority Over Standard-of-Care in Pivotal Clinical Trial; Edwards’ SAPIEN 3 Ultra RESILIA Valve Maintains Exceptional Patient Outcomes in Real-World Settings; Abbott Introduces AVEIR™ VR Leadless Pacemaker System to Indian Market; GE HealthCare’s Pristina Via Transforms Mammography with Improved Workflow and Patient Care

pharma-news-for-Ractigen-intellia -bridgebio

FDA Grants Orphan Drug Designation for Ractigen’s RAG-21 in ALS; Intellia’s Nexiguran RMAT for ATTR Amyloidosis; FDA Approves Acoramidis for ATTR-CM; Jazz Wins FDA Approval for Ziihera in HER2-Positive Biliary Cancer; J&J Seeks FDA Approval for Subcutaneous TREMFYA in Colitis

medtech-news-of-cartessa-logicmark-boston-scientific

Cartessa Aesthetics teams with Classys for Everesse; LogicMark unveils Freedom Alert Max; GE HealthCare clears SIGNA MAGNUS MRI; OMRON’s BP monitor with AI-powered AFib detection gets FDA approval; Boston Scientific’s WATCHMAN FLX™ cuts bleeding risk; Encora Therapeutics wraps ULTRE trial for tremor device

pharma-news-for-regeneron-astrazeneca-syndax

FDA Approves PTC’s AADC Gene Therapy; DUPIXENT sBLA Acceptance for Urticaria; CHMP Recommends TAGRISSO for EGFR Lung Cancer; FDA Approves DANZITEN for CML; Syndax Wins FDA Approval for REVUFORJ in Acute Leukemia

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