The FDA announced several regulatory actions the past few weeks.
Here is an overview of decisions that may be relevant to your practice.
1. The agency granted fast track designation to AB-101 (Artiva Biotherapeutics), a nongenetically modified, cord blood-derived, allogenic, cryopreserved, antibody-dependent cell-mediated-toxicity-enhancing natural killer cell therapy. The indication is for treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin in combination with rituximab.
2. The FDA granted orphan drug designation to JBI-778 (Jubilant Therapeutics) for the treatment of

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