Urgent Recall Issued for Nobivac DHPPi Veterinary Injection for Dogs
On October 15, 2025, Swissmedic announced a batch recall of the veterinary medicine Nobivac DHPPi, a lyophilisate designed for the…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Europe
Europe
Swissmedic Highlights Regulatory Focus on Parenteral Cosmetic Products
Swissmedic has released key insights on parenteral products in the cosmetic sector. This update, published on October 13, 2025, emphasizes…
Latest News
FDA Issues Boxed Warning Update for CARVYKTI Over Rare Enterocolitis Risk
The U.S. Food and Drug Administration (FDA) has issued updated labeling for Ciltacabtagene Autoleucel (CARVYKTI), a treatment for certain patients…
Latest News
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 Impella Controller (AIC) used…
Europe
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 precision oncology. This pivotal…
Europe
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 a refined update to…
Europe
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 a significant step forward…
Europe
Swissmedic Announces First Authorization for Blenrep®
Swissmedic has officially announced the first authorization of Blenrep®, marking a significant regulatory milestone in its approval process. Clinical, quality,…
Europe
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 opportunity for experienced professionals.…
Latest News
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 a specific lot of…
Europe
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 opportunities at an 80-100%…
Europe
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 HC 100 mg film-coated…
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