Global updates on medical device regulation and quality.
441 articles
Swissmedic, Switzerland’s authority for therapeutic products, has announced the self-declaration deadline for the 2025 oversight fee. Medical device manufacturers, clinical…
On December 5, 2025, Swissmedic announced an extension to the therapeutic indication for Jemperli®, emphasizing its crucial role in the…
On December 5, 2025, Swissmedic published an update regarding the therapeutic indication of Tevimbra®. This regulatory decision expands the scope…
Swissmedic, the Swiss Agency for Therapeutic Products, has officially announced the approval of an extended therapeutic indication for Tevimbra®. This…
The U.S. Food and Drug Administration (FDA) has granted conditional approval for Exzolt Cattle-CA1 (fluralaner), a topical solution designed to…
The U.S. Food and Drug Administration (FDA) has issued its approval for Breyanzi (lisocabtagene maraleucel) as the first-ever Chimeric Antigen…
The U.S. Food and Drug Administration (FDA) has approved Avance (acellular nerve allograft-arwx), marking a significant advancement in the treatment…
Swissmedic has issued an important update regarding Rhophylac® (human anti-D immunoglobulin), alerting healthcare professionals of a contamination risk associated with…
The U.S. Food and Drug Administration (FDA) announced the appointment of Tracy Beth Høeg, M.D., Ph.D., as the acting director…
The FDA has issued an Early Alert regarding a significant safety concern involving certain glucose monitor sensors manufactured by Abbott…
On December 3, 2025, the FDA announced a significant correction related to Olympus’s Single Use Ligating Device PolyLoop. This update…
Swissmedic, Switzerland’s medical regulatory authority, has announced an extension of the approved therapeutic indication for the cancer treatment Welireg®. This…