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Anaphylm

Pharma & Biotech

Why Aquestive’s Anaphylm is back at FDA after a pouch problem derailed approval

Aquestive Therapeutics has resubmitted its Anaphylm application after responding to FDA concerns over packaging and administration, putting the potential needle-free, orally delivered emergency treatment for anaphylaxis back on a regulatory path toward the U.S. market.

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Pharma & Biotech

What Aquestive Therapeutics’ Anaphylm CRL reveals about human factors scrutiny in emergency-use drug approvals

FDA halts Anaphylm over human factors risks. Find out what this means for non-injectable epinephrine and future anaphylaxis treatments.

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