Aimmune’s Palforzia Gains US FDA Panel Nod But Faces REMS Restrictions
The agency’s plan to require a Risk Evaluation and Mitigation Strategy aimed at systemic allergic reactions with the peanut allergy immunotherapy did not go far enough, advisory committee members said, pushing for additional measures to be folded into the program.
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Palforzia Peanut Allergy Immunotherapy: Aimmune CEO On REMS Restrictions, Manufacturing
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Aimmune Expects ‘Robust’ Demand For Peanut Allergy Treatment Palforzia, Though Slow Launch
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Keeping Track: Aimmune’s Peanut Allergen Approved; Novartis’ Inclisiran, Pfizer/Lilly’s Tanezumab, Bayer’s Nifurtimox Submitted
Highlights of the latest drug development news from our US FDA Performance Tracker.