News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
The Danish company Bavarian Nordic plans to supply up to 2 million vaccine doses this year in response to the World Health Organization’s declaration of mpox as a Public Health Emergency of International Concern (PHEIC) earlier this month.
The US FDA has granted approval to Niktimvo for the treatment of chronic graft-versus-host disease, a serious immune condition affecting the recipients of stem cell transplants.
Two months after placing a partial hold on a phase 1 clinical trial evaluating an antibody-drug conjugate (ADC) in cancer patients, the FDA is allowing the study to proceed with the lower doses of the treatment.