Researchers engineered IgA antibodies from IgG monoclonals, enhancing neutralization against Omicron by up to 75-fold and offering protection in mice models.
Marks: FDA open to using single-arm studies for accelerated approval of rare disease gene therapies
Peter Marks, the FDA official who oversees gene therapies, is again advocating for the use of accelerated approvals for gene therapies that treat rare diseases.
November 28, 2023