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Novartis’ LUTATHERA for GEP-NET Treatment: Ray of Hope for Pediatric Patients

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Pharma News for Gilead, Incannex, Avidity

Eylea HD Injection 8 Mg Approved By FDA; Veopoz Receives FDA Approval for CHAPLE Disease Treatment; FDA Places Second Partial Clinical Hold on AML Enrollment for Magrolimab Trials; FDA Approval to Incannex’s Sleep Apnoea Clinical Trial; FDA Orphan Drug Designation to Avidity’s AOC 1044; Orphan Drug Designation to CanariaBio’s MAb-AR20.5

Pharma News for Janssen, Galera, Genprex

J&J’s 2-in-1 Tablet for Prostate Cancer; FDA Approves TALVEY for Heavily Pretreated Multiple Myeloma; PDS Biotech Updated on VERSATILE-003 Trial; FDA Issues CRL to NDA for Avasopasem in Radiotherapy-Induced Severe Oral Mucositis in HNC; FDA Orphan Drug Designation to Genprex’s REQORSA; FDA Orphan Drug Designation to Bloomsbury’s BGT-OTCD

MedTech News for Quest, DuPont, BD

Quest Introduced Consumer-Initiated Blood Test for Alzheimer’s Disease Risk Assessment; DuPont Acquires Spectrum Plastics; BD Received 510(k) Clearance for Molecular Combination Test; Natera Updates on Phase III ALTAIR Trial of Signatera; Anteris’ DurAVR transcatheter heart valve Trial

Diagnostic Precision: The Rise of Medical Imaging Technologies and Market Trends

MedTech News for icotec, Terumo, Genesis

Icotec’s VADER Pedicle System; Terumo BCT’ Reveos Automated Whole Blood Processing System; Genesis MedTech’s J-Valve Transfemoral System; STARmed Launched STARmed America in the USA

Pharma News for GSK, Biogen, Citius

FDA Expands GSK’s Jemperli Approval; Biogen to Acquire Reata Pharma; Enhertu Shows Survival Boost in HER2+ Solid Tumors; FDA Rejects Citius’ Revived IL-2 Therapy; FDA Fast Track designation to IVS-3001 for RCC; EU Orphan Drug Designation to Biohaven’s Taldefgrobep Alfa

MedTech News VARON, Biostrap, MediView XR, Magnus

VARON’s New VP Series Portable Oxygen Concentrator; Biostrap’s Wrist-Worn Digital Health Monitoring Device; MediView’s AR Navigation Platform; Beckman Coulter’s DxC 500 AU Chemistry Analyzer; Magnus Updated on Study Using SAINT Neuromodulation System; Francis Medical’s VAPOR 2 Pivotal Study

Pharma News for Gilead, Ambrx, Mirati

Gilead’s Magrolimab Plus Azacitidine for MDS; FDA Approveds VANFLYTA for Newly Diagnosed AML; FDA Awards Fast Track Designation to ARX517 mCRPC; EMA Rejects Mirati’s Krazati; Harmony Phase III Pitolisant Trial for PWS Patients; Belite Bio’s Phase 3 DRAGON Trial of Tinlarebant for STGD

MedTech News for Relievant, EarliTec, ReddyPort

Relievant Medsystems Launched Ablation System; Thermo Fisher’s Reproductive Health Assays; EarliTec’s Next-Generation EarliPoint Evaluation for ASD; FDA Cleared ReddyPort® Non-Invasive Ventilation Device; EndoTheia’s Novel Medical Device for Endoscopic Surgery; Neurolief’s MOOD Trial Interim Analysis

Pharma News for Eli Lilly, Alnylam, Elevar

Lilly to Acquire Versanis; FDA Approves Beyfortus for RSV in Infants; Alnylam Presented Updates on Interim Phase 1 Results for ALN-APP; FDA Accepts NDA for Rivoceranib Plus Camrelizumab; FDA Fast Track Designation to Karyopharm’s Selinexor; Adcentrx’s IND Application for ADRX-0706

MedTech News for ResMed, Stryker, OncoBeta

ResMed Acquired Somnoware; Stryker Launched Q Guidance System; AlloSource’s AceConnex Pre-Sutured Fascia; Urotronic’s Optilume BPH Catheter System; Verve Medical’s Pivotal Trial of RPD Renal Pelvic Denervation System; OncoBeta Provided Update on Rhenium-SCT

Pharma News Astellas, Eisai, Iovance, Biophytis

FDA Grants Priority Review for Zolbetuximab BLA; FDA Traditional Approval for LEQEMBI for Alzheimer’s Disease; Iovance Announces Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC; Biophytis Seeks FDA Approval to Launch Phase 3 Study of Potential Treatment of Sarcopenia; Orphan Drug Designation to Marker Therapeutics’s MT-401 for AML Treatment; Axsome Therapeutics Initiates Phase 3 Trial of Solriamfetol for ADHD

MedTech news for Eko. Haemonetics. Roche, Medtronic, Biodesix

GE HealthCare, DePuy Synthes Announced Collaboration; Eko Health Launched CORE 500 Digital Stethoscope; Haemonetics’s NexSys PCS Plasma Collection System; Roche’s Alzheimer’s Disease Cerebrospinal Fluid (CSF) Assays; Medtronic’s MiniMed 780G system; Biodesix’s VeriStrat Blood-Based Host Immune Classifier

Pharma News for Pfizer, Sarepta, FibroGen, Erasca

FDA Approves Jardiance for Type 2 Diabetes; FDA Approves Pfizer’s LITFULO for Alopecia Areata; Sarepta Therapeutics’s ELEVIDYS Approval; Tonix Pharmaceuticals to Acquire Two Migraine Products from Upsher-Smith; FibroGen’s Phase 3 ZEPHYRUS-1 Study of Pamrevlumab; FDA Orphan Drug Designation to ERAS-801 for Malignant Glioma

Pharma News for GSK, Roche, Avita, Ipsen

FDA Extended the Review Period for Momelotinib; FDA Approves Roche’s Columvi; Avita Medical Obtains FDA Approval of RECELL; FDA Approves Odevixibat for ALGS; TME Pharma Receives IND Approval for NOX-A12; Aldeyra’s Phase 3 INVIGORATE‑2 Trial of Reproxalap

Pharma News for Kyverna, Annovis, Astellas, FibroGen

FDA Fast Track Status to Kyverna’s KYV-101; Annovis’s Phase III Study for Buntanetap; Gilteritinib Demonstrated Benefit in AML Patients; FDA Orphan Drug Designation to DTx Pharma’s DTx-1252; FibroGen’s LELANTOS-1 Phase 3 Clinical Study Result

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