On 17 December 2025, Swissmedic announced an important regulatory update concerning the medication Ryeqo®. The approval…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Swissmedic Approves Temporary Distribution of Hibidil Sterile Solution in French Packaging
On December 17, 2025, Swissmedic approved a temporary measure allowing the distribution of Hibidil sterile solution…
Urgent Recall: Publix Maple Walnut Coffee Cake Labeling Error and Allergen Risk
The James Skinner LLC has issued a voluntary recall of Publix Maple Walnut Coffee Cake due…
Critical Updates: Field Safety Alerts Issued for Medical Devices (8–12 December 2025)
Medical device professionals should be aware of the latest Field Safety Notices (FSNs) published between 8–12…
FDA Broadens Use of Real-World Evidence for Drug and Medical Device Reviews
On December 15, 2025, the U.S. Food and Drug Administration (FDA) announced a major policy shift…
Critical Recall Alert: Prednisolone 5mg Soluble Tablets by Activase Pharmaceuticals
Activase Pharmaceuticals Limited has issued a Class 3 medicines recall for two specific batches of Prednisolone…
Swissmedic Announces Therapeutic Expansion for Blenrep®: Key Updates for Regulatory Teams
On December 13, 2025, Swissmedic announced the extension of the therapeutic indication for Blenrep®, signaling a…
FDA Grants Approval to Avance Nerve Scaffold for Treating Sensory Nerve Discontinuity
The U.S. Food and Drug Administration (FDA) has approved Avance (acellular nerve allograft-arwx), a novel nerve…
FDA Grants Regulatory Approval for Cellular Therapy to Address Severe Aplastic Anemia
The U.S. Food and Drug Administration (FDA) has taken a landmark step by granting approval for…
FDA Approves Augmentin XR under New Voucher Program to Boost Antibiotic Production
The U.S. Food and Drug Administration (FDA) has announced the first approval under the Commissioner’s National…