FDA Panel Approves Needle-Free Epinephrine Alternative for Anaphylaxis.

An advisory committee of outside experts to the FDA voted in favor of ARS Pharmaceuticals’ EpiPen alternative for adults and children, which would be the first epinephrine nasal spray on the US market. The FDA advisory committee's vote was a surprise as multiple members questioned the nasal spray’s benefit-risk profile and called for some clinical data on the nasal spray to be produced before it can be approved. Meanwhile, the FDA has rejected ImmunityBio’s biologics license application for a specific bladder cancer, and the biotech’s shares tumbled about 50% before the opening bell Thursday.