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.
You may also be interested in...
Aimmune CEO Jayson Dallas tells the Pink Sheet how physicians and patients are being certified to use Palforzia and how the product's food-based manufacturing process is actually an advantage.
Aimmune CEO Jayson Dallas talked to Scrip about the company's field team, allergists' and payers' responses to the first food-derived medicine, and why Viaskin Peanut patch is not a competitive threat.
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.