Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.
A US Food and Drug Administration advisory committee meeting on Biogen, Inc.’s Alzheimer’s drug aducanumab will offer some insight into the amount of flexibility the agency and its external experts are... Read more »
Gene therapy product developers are seeking more clarity from the US Food and Drug Administration on when viral vectors from the same class will be considered sufficiently different for purposes of... Read more »
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