North America
TCAI Becomes First in U.S. to Implant Leadless Cardiac Resynchronization Device
Electrophysiologists at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center recently became the first in the nation to implant an F...
July 21, 2025 | News
FDA Pulls Emergency Brake on Sarepta's Gene Therapy Trials Amid Fatal Safety Crisis
The U.S. Food and Drug Administration announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb girdle muscular dy...
July 21, 2025 | Regulatory
Thermo Fisher to Acquire Sanofi’s Ridgefield Site, Expanding U.S. Steriles Manufacturing Capacity
Thermo Fisher to Acquire Sanofi’s Steriles Manufacturing Site in Ridgefield, New Jersey to Produce Critical Medicines for Sanofi Enables Additional ...
July 17, 2025 | News
Thermo Fisher Scientific Expands Rapid CGP Access with Oncomine™ Comprehensive Assay Plus on Genexus™ System
Thermo Fisher Scientific announced that the Oncomine™ Comprehensive Assay Plus* is now available on the Ion Torrent™ Genexus™ System* hel...
July 15, 2025 | News
FDA Publishes First-Ever Public Database of Complete Response Letters (2020–2024) – Now Available for Download
Download Approved CRLs – 2020 to 2024 (external link) U.S. Food and Drug Administration (FDA) has, for the first time, made pub...
July 14, 2025 | Regulatory
Elegen and Nutcracker Therapeutics Launch Cell-Free Platform Pilot to Transform RNA-Based Personalised Cancer Therapeutics
Elegen, a global leader in next-generation DNA manufacturing, and Nutcracker Therapeutics, a global leader in next-generation RNA design and manufactu...
July 14, 2025 | News
Merck & Co. (MSD Outside U.S. and Canada) to Acquire Verona Pharma for $10 Billion, Expanding Respiratory Portfolio with Ohtuvayre®
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceu...
July 04, 2025 | News
Elevaris Medical Devices Accelerates Product Development with On-Site XLerator Live Prototyping Program
Elevaris Medical Devices, a Contract Development and Manufacturing Organization (CDMO) for industry-leading, multi-national healthcare companies, global me...
July 11, 2025 | News
I Peace and Vita Therapeutics Partner to Develop Universal Hypoimmune iPSC Lines for Cell Therapy
Leading GMP cell CDMO I Peace, Inc. specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the co...
July 11, 2025 | News
Earendil Labs Completes First Cohort Dosing in Phase 1 Trial of Novel Anti-TL1A Antibody HXN-1001
Earendil Labs, an AI-empowered biotechnology company, announced that it has completed cohort 1 dosing in a phase 1 trial for a novel anti-TL1A antibo...
July 11, 2025 | News
Univercells Technologies and Repligen Collaborate to Advance Real-Time Monitoring in Viral Vector and Vaccine Manufacturing
Univercells Technologies, a Donaldson Life Sciences business and global provider of bioprocessing solutions, announced a collaboration with Repli...
July 10, 2025 | News
Quanterix Completes Acquisition of Akoya Biosciences, Expanding Leadership in Multi-Tissue Biomarker Detection
Quanterix Corporation, a company fueling scientific discovery through ultra-sensitive biomarker detection, announced that it has completed its previously a...
July 09, 2025 | News
Sirtex Secures FDA Approval for SIR-Spheres® Y-90 in Treating Unresectable Hepatocellular Carcinoma
Sirtex Medical ("Sirtex"), a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (F...
July 08, 2025 | News
Celltrion Launches STOBOCLO® and OSENVELT® Biosimilars in the U.S. for Comprehensive Bone Health and Oncology Care
STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of PROLIA® (denosumab) and X...
July 08, 2025 | News
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- Aarian Health Appoints Thomas Keller as Business Director to Drive Innovation and Growth
- Top Management Shakeups of 2024: Redefining Pharma, Biopharma, and Biotech Leadership
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