Regulatory Affairs

December 17, 2025 Dr. Hatem Rabeh

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 in French-language packaging within…

December 17, 2025 Dr. Hatem Rabeh

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 to an incorrect labeling…

December 15, 2025 Dr. Hatem Rabeh

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 December 2025. These updates…

December 15, 2025 Dr. Hatem Rabeh

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 aimed at enhancing regulatory…

December 15, 2025 Dr. Hatem Rabeh

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 5mg Soluble Tablets as…

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 significant development in its…

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 scaffold, for surgical implantation…

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 Omisirge (omidubicel-onlv), a hematopoietic…

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 Priority Voucher (CNPV) pilot…

FDA Grants Historic Approval to Gene Therapy for Wiskott-Aldrich Syndrome

The U.S. Food and Drug Administration (FDA) has approved Waskyra (etuvetidigene autotemcel), marking a significant milestone as the first cell-based…

FDA Moves to Include Bemotrizinol in Sunscreen Formulations: A Regulatory Update

The U.S. Food and Drug Administration (FDA) announced a major step forward in sunscreen product development on December 13, 2025.…

FDA Authorizes Two New Oral Treatments for Gonorrhea, Marking a Regulatory Milestone

The U.S. Food and Drug Administration (FDA) has approved two novel oral therapies for gonorrhea, a significant milestone in addressing…