The U.S. Food and Drug Administration (FDA) has issued updated labeling for Ciltacabtagene Autoleucel (CARVYKTI), a…
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Urgent FDA Alert: Cybersecurity Vulnerability Identified in Abiomed’s Automated Impella Controller
On October 10, 2025, the FDA issued an alert regarding a cybersecurity vulnerability affecting the Automated…
CSMD-Horizon 2025 to Address MedTech AI, Digital Health and Regulation in Brussels
The CSMD-Horizon Special Conference for MedTech AI and Digital Health: Regulation, Market Access and Clinical Evidence…
Swissmedic Grants First Authorization for Balversa® in Targeted Cancer Treatment
On October 10, 2025, Swissmedic issued its first authorization for Balversa®, marking a significant milestone in…
Swissmedic Approves Extended Use for Spevigo®: Important Regulatory Update
Swissmedic has officially approved an extension of the therapeutic indication for Spevigo®. This regulatory decision marks…
Swissmedic Grants Initial Authorization for Voxzogo®: A Milestone for Regulatory Compliance
Swissmedic, the Swiss agency for therapeutic products, has officially granted the first authorization for Voxzogo®, marking…
Swissmedic Announces First Authorization for Blenrep®
Swissmedic has officially announced the first authorization of Blenrep®, marking a significant regulatory milestone in its…
New Horizon in Cardiac Care: US Benchmarking Clinical Study Targets Advanced Conditions
The medical device and clinical research community should note a significant development in cardiac care studies.…
Exploring High-Intensity Interval Training and Time-Restricted Eating: New Study Targets Type 2 Diabetes Risk Management
A groundbreaking clinical trial now recruiting aims to compare the impacts of High-Intensity Interval Training (HIIT)…
Emerging Evidence: Heavy Metal Exposure and Respiratory Health Risks from Vaping in Young Adults
On October 11, 2025, researchers at Ohio State University Comprehensive Cancer Center revealed a new clinical…