Zymark Corp.

Multiple leaders in the US Food and Drug Administration’s cell and gene therapy office are departing as the deadline for a decision on the buyout and early retirement offer looms. Among those leaving

The gene therapy office in the US Food and Drug Administration’s Center for Biologics Evaluation and Research has enticed a rising star from the Oncology Center of Excellence to run its clinical progr

Drug and biologic product sponsors should anticipate that US Food and Drug Administration review divisions will become more insistent in 2023, though perhaps not absolute, about the need for confirmat

The fiscal year 2023 US government funding bill moving through Congress this week includes accelerated approval pathway reforms aimed at giving the Food and Drug Administration more authority to ensur