Oncology

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Moderna’s mRESVIA(R) FDA Approval; Novartis Scemblix® Phase III Data; Kite’s Tecartus for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia; Astellas’ Zolbetuximab Biologics License Application; CHMP Recommends AstraZeneca’s Tagrisso

FDA Greenlights Moderna's RSV Vaccine mRESVIA(R) Moderna, Inc. has announced that the FDA has approved mRESVIA (mRNA-1345), an mRNA-based vaccine for respiratory syncytial virus (RSV), to protect adults aged 60 and over from lower respiratory tract infections caused by RSV. This approval, granted under a breakthrough therapy designation, represents Moderna's second approved mRNA product. "The FDA approval of our second product, mRESVIA, highlights the robustness and adaptability of our mRNA platform," stated Stéphane Bancel, CEO of Moderna. "mRESVIA offers protection to older adults against severe RSV infection and is uniquely available in a pre-filled syringe,...

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The Rise of TCR Therapy: A Beacon of Hope in Cancer Treatment

HPK1 Inhibitors: A Promising Frontier in Immuno-Oncology Therapeutics

MedTech News for Savara, CRVx, Gore, Masimo

Savara Introduced aPAP ClearPathTM; RaySearch Released RayStation 2024A; FDA Approved Expanded Label for CVRx Neuromod Tech; FDA Clearance to Masimo’s Baby Monitoring System; Kansas City Proton Institute’s Advanced MEVION S250i Proton Therapy System; Gore’s Arise II Pivotal Study of the Gore® Ascending Stent Graft

Blood Cancer Diagnostics Market Dynamics

Blood Cancer Diagnostics: Exploring Key Factors and Major Dynamics Shaping the Market Outlook

MedTech News for Integra, B. Braun, Medtronic, Perfuze

Integra to Buy J&J’s Acclarent; B. Braun Launches the CARESITE Micro Luer Access Devic; FDA Approves Medtronic’s Novel PulseSelect Pulsed Field Ablation System; FDA Clearances to Perfuze’s Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment; ShiraTronics Successfully Implants First Migraine System; Sight Sciences Announced the Six-Month Results For Heat Therapy Device

Pharma News for Eisai, Biogen, Merck, BMS, Kyverna

Eisai Submits Marketing Authorization Application for Tasurgratinib; CHMP Issues Positive Opinion for Biogen’s SKYCLARYS; European Commission Approves Merck’s KEYTRUDA + Chemotherapy HER2-ve Gastric or GEJ Adenocarcinoma; BMS Provides Update on RELATIVITY-123 Trial; Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101; Verrica and Torii Pharma Announces Positive Top-line Results from a Confirmatory Phase 3 Trial of TO-208

Harmony in Treatment: GOLCA (golcadomide) Reveals Favorable Safety Profile and Seamless Integration with R-CHOP for Untreated Aggressive B-Cell Lymphoma

Breaking Ground: Ibrutinib and Venetoclax Synergy Delivers Significant Progression-Free Survival Boost in Relapsed/Refractory Mantle Cell Lymphoma

BGB-16673 Breakthrough: A Tolerable Triumph in Rapid Clinical Responses for Relapsed/Refractory B-Cell Malignancies

TALVEY’s Versatility Shines: Key Insights from MonumenTAL-2 Study Illuminate Effective Strategies in Relapsed/Refractory Multiple Myeloma

MedTech News for AcelRx, Kaneka, ZimVie, NeuroOne

Micro Medical Solutions’s Pivotal STAND Clinical Trial; AcelRx’s Continuous Renal Replacement Therapy; Kaneka Acquired Japan Medical Device Technology; Tandem Diabetes Care Launched t:slim X2 Insulin Pump Software; ZimVie’s Vital Spinal Fixation System and Brainlab Spine & Trauma Navigation; NeuroOne’s OneRF Ablation System

Breakthrough Success: AUGMENT-101 Trial Hits Primary Endpoint with Consistent CR/CRh Rates Across Adult and Pediatric KMT2Ar AML and ALL Cohorts

DARZALEX FASPRO Quadruplet Regimen Demonstrates Striking Advancements in Treatment Outcomes for Newly Diagnosed Multiple Myeloma Eligible for Transplantation

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Analysis & Perspective

Oncology

Moderna’s mRESVIA(R) FDA Approval; Novartis Scemblix® Phase III Data; Kite’s Tecartus for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia; Astellas’ Zolbetuximab Biologics License Application; CHMP Recommends AstraZeneca’s Tagrisso

The Rise of TCR Therapy: A Beacon of Hope in Cancer Treatment

HPK1 Inhibitors: A Promising Frontier in Immuno-Oncology Therapeutics

Blood Cancer Diagnostics: Exploring Key Factors and Major Dynamics Shaping the Market Outlook

Harmony in Treatment: GOLCA (golcadomide) Reveals Favorable Safety Profile and Seamless Integration with R-CHOP for Untreated Aggressive B-Cell Lymphoma

ALLO-647 Integration in Lymphodepletion: Paving the Way for Enduring Responses and Safe CAR T cell Therapy Advancements

More Views & Analysis

Golcadomide and Rituximab Combo Unveils Promising Efficacy in Heavily Pretreated Relapsed/Refractory DLBCL

Pioneering Progress: ZYNLONTA and Rituximab Combo Delivers Striking 96% Overall Response in Relapsed Follicular Lymphoma

Breaking Ground: Ibrutinib and Venetoclax Synergy Delivers Significant Progression-Free Survival Boost in Relapsed/Refractory Mantle Cell Lymphoma

BGB-16673 Breakthrough: A Tolerable Triumph in Rapid Clinical Responses for Relapsed/Refractory B-Cell Malignancies

TALVEY’s Versatility Shines: Key Insights from MonumenTAL-2 Study Illuminate Effective Strategies in Relapsed/Refractory Multiple Myeloma

Breakthrough Success: AUGMENT-101 Trial Hits Primary Endpoint with Consistent CR/CRh Rates Across Adult and Pediatric KMT2Ar AML and ALL Cohorts

DARZALEX FASPRO Quadruplet Regimen Demonstrates Striking Advancements in Treatment Outcomes for Newly Diagnosed Multiple Myeloma Eligible for Transplantation

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