Eli Lilly has finally achieved FDA approval for its monoclonal antibody Alzheimer’s therapy donanemab, bringing new competition to the field for Eisai and Biogen.
RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.
Hot on the heels of last year’s EU approval of Hemgenix, the first gene therapy for the blood disorder hemophilia B, the UK and Denmark are the latest European nations to take steps to pay for the treatment.
The US FDA has delayed approval of Rocket Pharmaceuticals’ gene therapy for treatment of a rare immune condition known as leukocyte adhesion deficiency, citing a need for more information about the manufacturing process.
