Tag: breakthrough therapy designation

Dupixent (dupilumab)

FDA Approves First Treatment for Eosinophilic Esophagitis (EoE), a Chronic Immune...

EoE is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the tissue of the esophagus.
Omalizumab + OIT

Clinical Trial to Evaluate Experimental Treatment in People Allergic to Multiple...

NIH and partners to assess whether Omalizumab can reduce allergic reactions.
Xolair (omalizumab)

FDA Grants Xolair Breakthrough Therapy Designation for Food Allergies

Breakthrough Therapy Designation was granted on the basis of data from seven clinical studies assessing the efficacy and safety of Xolair against a range of food allergens including peanut, milk, egg and others.
Paliforzia (AR101)

Aimmune Begins Patient Enrollment for Phase III Clinical Trial of Peanut...

First of 440 patients enrolled in study of AR101.

Breakthrough Food Allergy Therapies and the Big Business Behind Them

What it means to be a breakthrough therapy, who is developing them, how they work, and the (big) business drivers behind them.