The US FDA is considering labeling that calls greater attention to the symptoms of amyloid-related imaging abnormalities to ensure proper treatment and avoid misclassification as ischemic stroke.
The US Food and Drug Administration’s review and expected approval of Eli Lilly and Company’s donanemab could lead to another safety labeling update for the class of anti-amyloid therapies in Alzheimer’s disease.
The agency is considering requiring that labeling and other materials call greater attention to the symptoms of amyloid-related imaging abnormalities...
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
