The U.S. Food and Drug Administration (FDA) has issued its approval for Breyanzi (lisocabtagene maraleucel) as…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
FDA Grants Approval for Avance Nerve Scaffold to Treat Sensory Nerve Damage
The U.S. Food and Drug Administration (FDA) has approved Avance (acellular nerve allograft-arwx), marking a significant…
Swissmedic Warns of Particle Contamination in Rhophylac® (Anti-D Immunoglobulin)
Swissmedic has issued an important update regarding Rhophylac® (human anti-D immunoglobulin), alerting healthcare professionals of a…
FDA Appoints Acting Director for Center for Drug Evaluation and Research
The U.S. Food and Drug Administration (FDA) announced the appointment of Tracy Beth Høeg, M.D., Ph.D.,…
FDA Issues Early Alert on Glucose Monitor Sensor Risks from Abbott Diabetes Care
The FDA has issued an Early Alert regarding a significant safety concern involving certain glucose monitor…
Critical Update: Olympus Modifies Use Instructions for Single Use Ligating Device PolyLoop
On December 3, 2025, the FDA announced a significant correction related to Olympus’s Single Use Ligating…
Swissmedic Expands Therapeutic Indication for Welireg®
Swissmedic, Switzerland’s medical regulatory authority, has announced an extension of the approved therapeutic indication for the…
FDA Proposes New Measures to Minimize Non-Human Primate Testing for Monoclonal Antibody Development
The U.S. Food and Drug Administration (FDA) has released proposed guidance aimed at reducing or eliminating…
FDA’s Coordinated Crackdown: $1 Million Worth of 7-OH Opioids Seized in Missouri
The U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Justice (DOJ),…
Swissmedic Opens Recruitment for Experienced Software Architect in Regulatory IT
Swissmedic, Switzerland’s key authority for the oversight of therapeutic products, has recently issued a call for…