Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. The rejection and request for additional testing sharply contrasts the backing from the U.S. Food and Drug Administration's (FDA) independent experts for the spray, neffy, in May. EpiPen-maker Viatris (VTRS.O) had in June petitioned the FDA to require that ARS conduct more trials that closely mimic real-world conditions. It did not test neffy in anaphylaxis, a severe, life-threatening allergic reaction, due to ethical concerns. ARS expects to re-submit its application in the first half of 2024, with an FDA decision likely in the second half.

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Persons: Andrew Kelly, William Blair, Tim Lugo, Stacey Saiontz, anaphylaxis, James Tarbox, Christy Santhosh, Sriparna Roy, Jahnavi, Varun Organizations: Food and Drug Administration, FDA, REUTERS, ARS Pharmaceuticals, U.S . Food, Pharma, Regulators, ARS, Texas Tech University Health Sciences Center, Thomson Locations: White Oak , Maryland, U.S, anaphylaxis, Bengaluru