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NDA Submission for Anaphylm (Epinephrine) Sublingual Film on Track for Q1 2025, Company Says / image credit ©New Africa/stock.adobe.com
NDA Submission for Anaphylm (Epinephrine) Sublingual Film on Track for Q1 2025, Company Says

December 3rd 2024

Aquestive Therapeutics announced positive feedback from the FDA this week that keeps NDA planning for the novel epinephrine product on solid ground.

FDA Accepts Dupilumab sBLA for Review for Treatment of Chronic Spontaneous Urticaria / Image credit: ©chomplearn 2001/AdobeStock
FDA Accepts Dupilumab sBLA for Review for Treatment of Chronic Spontaneous Urticaria

November 15th 2024

FDA May End Use of Oral Phenylephrine as Nasal Decongestant Ingredient in OTC Products
FDA May End Use of Oral Phenylephrine as Nasal Decongestant Ingredient in OTC Products

November 8th 2024

Knowledge Gaps in How to Manage Anaphylaxis, Epinephrine Use, Persist for Patients, Even EMS / image credit ©TOImages/stock.adobe.com
Knowledge Gaps in How to Manage Anaphylaxis, Epinephrine Use, Persist for Patients, Even EMS

October 28th 2024

©Rawpixel/shutterstock.com
sNDA Goes to FDA for neffy 1 mg for Young Children with Type 1 Allergic Reactions

September 11th 2024

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