The U.S. Food and Drug Administration (FDA) has issued updated labeling for Ciltacabtagene Autoleucel (CARVYKTI), a…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
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…
Swissmedic Opens Recruitment for Financial Leadership Role in Compliance-Focused Environment
Swissmedic, Switzerland’s authority responsible for the authorization and monitoring of therapeutic products, has announced a new…
Trividia Health Initiates Precautionary Recall of Certain TRUE METRIX Blood Glucose Meters Due to Display Issue
Trividia Health, Inc., a leading global health and wellness company, has initiated a voluntary recall of…
Swissmedic Opens Clinical Assessor Positions: A Vital Role in Regulatory Oversight
Swissmedic has officially announced openings for Clinical Assessors within its Division of Clinical Assessment, offering employment…
Swissmedic Issues Recall for Select Batches of ASS Cardio Spirig HC 100 mg Film-Coated Tablets
On October 8, 2025, Swissmedic issued an immediate recall for specified batches of ASS Cardio Spirig…