Over the past decade, gene editing technologies, particularly CRISPR/Cas9 and its derivatives, have rapidly advanced, enabling more precise and efficient genetic modifications. This progress offers new possibilities for better understanding life processes and...
Adaptimmune has achieved a significant milestone with the FDA’s accelerated approval of Tecelra (afami-cel), a groundbreaking cell therapy for metastatic or unresectable synovial sarcoma. This approval marks several firsts in the field of cancer treatment:...
The EveryLife Foundation for Rare Diseases commends the Food and Drug Administration (FDA) on today’s announcement of its intention to create a Rare Disease Innovation Hub. Co-chaired by CDER Director, Dr. Peter Marks, and CBER Director, Dr. Patrizia Cavazzoni,...
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD. The filing comes after...
The biggest news of the week was the FDA approval of Eli Lilly’s Kisunla (donanemab) on Tuesday. While not unexpected, it was one of the year’s most highly anticipated decisions. And last week saw another big approval from the FDA—that of Verona’s novel COPD drug. But...