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Thursday, July 3, 2025

Tag: safety profile

Dizal’s ZEGFROVY® (sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

ZEGFROVY is the only approved targeted oral treatment for NSCLC with EGFR exon20insApproval follows the U.S. FDA's Priority Review and is supported by the pivotal WU-KONG1 Part B study, in which...

Marengo Presents Monotherapy Activity of Invikafusp Alfa, a First-in-Class Selective Dual T Cell Agonist in PD-1 Resistant GI Tumors, as a Late-Breaking Oral Presentation...

Promising monotherapy activity observed in all three major metastatic colorectal cancer subtypes harboring high tumor mutational burden (MSS RASwt, MSS RASmut and PD-1 resistant MSI-H)...

Jazz Pharmaceuticals Receives European Commission Marketing Authorization for Ziihera® (zanidatamab) for the Treatment of Advanced HER2-Positive Biliary Tract Cancer

– Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial – DUBLIN, July 1, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ)...

HanchorBio and Henlius Sign Major Licensing Deal for HCB101 to Expand Global Immuno-Oncology Reach

TAIPEI and SHANGHAI and SAN FRANCISCO, July 1, 2025 /PRNewswire/ -- HanchorBio Inc. (7827.TWO), a global clinical-stage biotechnology company developing innovative immunotherapies for oncology...

HUTCHMED Announces China Approval for ORPATHYS® in Combination with TAGRISSO® for the Treatment of Lung Cancer Patients with MET Amplification After Progression on First-Line...

— Approval based on Phase III SACHI Trial results which showed a 66% reduced risk of progression or death as compared to platinum-based chemotherapy —

New Data for Nusinersen Underscore Biogen’s Commitment to Advancing Clinical Research to Improve Outcomes in SMA

CAMBRIDGE, Mass., June 27, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced new data that reinforce the clinical impact of nusinersen across a broad spectrum of individuals affected by spinal muscular atrophy (SMA). These latest findings from Part C of the DEVOTE trial evaluating a higher dose regimen of nusinersen and the NURTURE trial which evaluated the approved 12 mg regimen (SPINRAZA®) in clinically presymptomatic SMA were presented at the SMA Research & Clinical Care Meeting hosted by Cure SMA in Anaheim, Calif. Biogen’s applications for the higher dose regimen of nusinersen are currently under review in the U.S., Europe, Japan and other global markets. The higher dose regimen of nusinersen comprises a more rapid loading regimen – two 50 mg doses 14 days apart – and a higher maintenance regimen – 28 mg every four months.

UCB announces positive results from GEMZ Phase 3 study of fenfluramine in CDKL5 deficiency disorder

Phase 3 study met primary and most key secondary clinical endpointsThis marks the third developmental and epileptic encephalopathies (DEE) population for fenfluramine with positive phase...

Cellarity Initiates Phase 1 Clinical Study of CLY-124, a First-in-Class Globin-Switching Oral Medicine for the Treatment of Sickle Cell Disease

Initiation follows successful IND clearance based on preclinical data package indicating robust increase in fetal hemoglobin with no cytotoxicity Novel Globin-Switching mechanism derived from...

BioCity’s ETA-Selective Antagonist SC0062 Granted Breakthrough Therapy Designation in China for Diabetic Kidney Disease with Albuminuria

Second BTD Recognition Highlights Compound's Potential as Next-Generation Broad-Spectrum Renal TherapySHANGHAI, June 25, 2025 /PRNewswire/ -- BioCity Biopharma ("BioCity") announced today that the Center for...

CARsgen Therapeutics Announces NDA Acceptance of Satri-cel by China’s NMPA

SHANGHAI, June 25, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that...

ProZenith Ingredients Researched: The Science Behind the Popular Formula

Plant-Based Ingredients, Scientific Research, and Mineral Synergy Come Together in This Modern Approach to Natural Weight Support
Plant-Based Ingredients, Scientific Research, and Mineral Synergy Come Together in This Modern Approach to Natural Weight Support

Wall Street Eyes Breakout Cancer Therapies Amid Soaring Drug Prices

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 24, 2025 /PRNewswire/ -- Equity Insider News Commentary – Rising rates of cancer...

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