Swissmedic, Switzerland’s key regulatory authority for therapeutic products, has outlined measures to strengthen its financial position.…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Supreme Deli LLC Recalls Boar’s Head Pecorino Romano Cheese Over Listeria Risks
Supreme Deli LLC, conducting business as Supreme Service Solutions, has announced a voluntary recall of specific…
FDA Grants Approval for Gene Therapy Addressing Spinal Muscular Atrophy Treatment Needs
The U.S. Food and Drug Administration (FDA) has officially approved Itvisma (onasemnogene abeparvovec-brve), a gene therapy…
Critical Updates: Field Safety Notices Issued from 10–14 November 2025
Between 10 and 14 November 2025, significant Field Safety Notices (FSNs) were announced, carrying potential implications…
FDA Issues Critical Recall Alert for Intersurgical i-View Video Laryngoscopes
On November 22, 2025, the FDA released details regarding a significant recall of the i-View Video…
Critical Update: Revised Instructions for Flexicare BritePro Solo Devices in Medline Kits
Medline Industries, LP has issued an urgent revision to the use instructions for Medline medical convenience…
Swissmedic Confirms First Authorisation for Lutathera®: Key Regulatory Update
On November 22, 2025, Swissmedic published an important regulatory update announcing the first authorisation of Lutathera®,…
Swissmedic Expands Use of Breyanzi®: Updated Authorization Details
On November 22, 2025, Swissmedic announced the extension of the therapeutic indication for Breyanzi® (lisocabtagene maraleucel).…
Swissmedic Authorizes 18F-PSMA-1007 ZRP®: Key Insights for Regulatory and Clinical Teams
On November 22, 2025, Swissmedic officially granted the first authorization of 18F-PSMA-1007 ZRP®. This approval represents…
Swissmedic Grants First Authorisation of Radelumin®: A Regulatory Milestone
Swissmedic has announced the first authorisation of Radelumin®, marking a significant regulatory achievement. Effective November 22,…