The U.S. Food and Drug Administration (FDA) has issued updated labeling for Ciltacabtagene Autoleucel (CARVYKTI), a…
Author: H RA
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…
Unapproved Medical Device Trial Sparks Regulatory Questions in the U.S.
On October 11, 2025, news surfaced about a clinical trial investigating a device that has not…
New Clinical Trial to Compare CAD/CAM vs Conventional Metallic Denture Frameworks for Mandibular Kennedy Class III Cases
Cairo University is set to launch a groundbreaking clinical trial to compare the performance and durability…
Palmar Cooling Trial Concludes: Insights into Immune Response Modulation Using Temperature Control Devices
Clinical researchers at Stanford University and the Wu Tsai Human Performance Alliance have completed a groundbreaking…