The U.S. Food and Drug Administration (FDA) has released an updated safety communication regarding the Hintermann…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Swissmedic Grants Initial Authorisation for Filsuvez®: A Key Milestone in Advanced Therapies
Swissmedic, the Swiss agency for therapeutic products, has announced the first authorisation of Filsuvez®, marking a…
Swissmedic Announces New Role for Laboratory IT Systems Specialist in OMCL
Swissmedic, Switzerland’s surveillance authority for medicines and medical devices, has disclosed an exciting new opportunity in…
Swissmedic Authorises New Therapeutic Use for Trecondi®
Swissmedic has announced an update regarding the medication Trecondi®. On October 31, 2025, the regulatory body…
Swissmedic Grants First Authorisation for SWAN-PSMA-1007®: Key Regulatory Insights
On October 31, 2025, Swissmedic announced the first authorisation of SWAN-PSMA-1007®, marking a significant regulatory milestone.…
Swissmedic Updates Position Paper on Decentralised Clinical Trials: Key Changes Explained
On October 31, 2025, Swissmedic and swissethics announced an update to their position paper on decentralised…
Swissmedic Approves Extended Therapeutic Indication for Omvoh®
Swissmedic has announced an important update regarding the therapeutic scope of Omvoh®. The newly approved indication…
Safety Alert: Recall of NaCl B. Braun Infusion Solution Batch
Swissmedic has issued an announcement regarding the immediate recall of batch number 251347651 of NaCl B.…
FDA Accelerates Biosimilar Approvals to Cut Treatment Costs for Chronic Diseases
The U.S. Food and Drug Administration (FDA) has announced measures to streamline the development of biosimilar…
Zingerman’s Recall: Allergy Hazard Due to Undeclared Peanuts & Cashews
Zingerman’s Candy Manufactory, based in Ann Arbor, Michigan, has issued an urgent recall concerning two of…