• Hikma’s epinephrine nasal spray for anaphylaxis cleared key regulatory review milestones in the US, Europe, and the UK.
• FDA accepted the New Drug Application for review under the 505(b)(2) pathway.
• European hybrid marketing authorisation dossier accepted via the decentralised procedure; UK filing accepted under the national route.
• A separate regulatory submission was filed in Canada.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Hikma Pharmaceuticals plc published the original content used to generate this news brief on September 09, 2026, and is solely responsible for the information contained therein.