FDA Approves Enable Injections’ Wearable Injector

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The injector is designed for at-home or in-clinic use.

Enable Injections’ announced that FDA has approved its wearable injector.

The Empaveli Injector is a wearable device designed for adults suffering from paroxysmal nocturnal hemoglobinuria. It allows for hands-free drug delivery of up to 25 mL and can be used for at-home or in-clinic use.


In a press release, Enable Injections’ CEO Michael Hooven said, “The approval of the EMPAVELI Injector will enhance the patient experience of administering a large volume (20 mL) of subcutaneous therapy. Enable's purpose is to redefine drug delivery for the benefit of patients.

He continued, “We are excited about achieving this milestone and are looking forward to growing enFuse® partnerships to improve the patient experience around the world."


(Oct. 2, 2023); Enable Injections, Inc.; Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval; https://www.prnewswire.com/news-releases/enable-injections-receives-first-us-food-and-drug-administration-fda-approval-301943542.html