Swissmedic has announced an important update to its Vigilance-News publication, ensuring accessibility for a broader audience.…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Swissmedic Releases Haemovigilance Annual Report 2024 With Key Findings on Transfusion Safety
Swissmedic, the Swiss agency for therapeutic products, has published its Haemovigilance Annual Report for the year…
FDA Adds High-Profile Warning to Elevidys Label Amid Fatal Liver Injury Reports
The U.S. Food and Drug Administration (FDA) has approved a significant update to the labeling of…
FDA Issues Guidance on Unauthorized Anti-Choking Devices: Follow Proven Rescue Protocols
The Food and Drug Administration (FDA) has issued an important update encouraging the public to use…
Swissmedic Issues Recall for GlucoSaline B. Braun Infusion Solution Batch
Swissmedic has announced a recall of batch number 242867651 for the product GlucoSaline B. Braun Infusion…
Swissmedic Updates: Safety Revisions to Product Information Starting November 2025
Swissmedic has announced a significant update regarding the publication of safety-related revisions to product information. Effective…
Swissmedic Announces Initial Authorisation of ZYNYZ® – Key Updates for Industry Professionals
Swissmedic has granted the first authorisation for ZYNYZ®, marking a significant regulatory milestone. This development signals…
Swissmedic Grants First Authorization for DATROWAY®: A Regulatory Milestone
On November 14, 2025, Swissmedic officially announced the first authorization of DATROWAY®, marking an important step…
Swissmedic Grants First Authorization for Pylclari®: Key Updates for Regulatory Teams
On November 14, 2025, Swissmedic officially announced the first regulatory authorization of Pylclari®, marking an important…
Swissmedic Announces Enhanced Use of Enhertu® for Extended Therapeutic Indications
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has announced the authorization of an extended therapeutic indication…