The U.S. Food and Drug Administration issued a Complete Response Letter regarding DBV Technologies’ Biologics License Application (BLA) for investigational Viaskin Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.
Treatments for peanut allergy and Parkinson’s disease are among U.S. drug launches that have been postponed by the COVID-19 pandemic as drugmakers struggle with disruptions to business, a Reuters review of filings and interviews with executives show.
DBV Technologies is cutting jobs while awaiting news from the U.S. Food and Drug Administration about the company’s approval application for Viaskin Peanut.
Aimmune Therapeutics Inc. said 80 percent of patients being treated with the company’s Palforzia were successfully desensitized to peanut proteins after two years of daily dosing.
The U.S. Food and Drug Administration approved Aimmune Therapeutics’ oral immunotherapy Palforzia as a first-of-its-kind treatment for the millions of people suffering from an allergy to peanuts.
France-based DBV Technologies released positive long-term data that could boost the chances of U.S. FDA approval for the company’s Viaskin Peanut allergy treatment.
Aimmune Therapeutics presented new data on the company’s AR101 peanut allergy therapy as well as a real-world data study at the American College of Asthma, Allergy and Immunology (ACAAI) Annual Scientific Meeting in Houston.
The U.S. Food and Drug Administration accepted for review the Biologics License Application (BLA) for DBV Technologies’ investigational Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.
A U.S. Food and Drug Administration advisory panel recommended approving the first therapy for peanut allergies, which affect over 1.6 million children in the United States, despite raising concerns about the risk of severe allergic reactions Palforzia poses to young patients.
After an eight month delay, France-based DBV Technologies announced the resubmission of a Biologics License Application to the U.S. FDA for the non-invasive allergy patch Viaskin Peanut.