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.
The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.
EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a study that concludes patients might need expensive refills less often.
Almost three in four U.S. allergy specialists are prescribing tablets to ease symptoms caused by pollen, ragweed and dust at least some of the time, though they have not completely shifted away from allergy shots, a survey suggests.
Aimmune Therapeutics announced that the Brisbane, Calif.-based company’s Phase III European clinical trial of AR101 for the treatment of peanut allergy met the primary efficacy endpoint.
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Pfizer Inc. received a request for documents as part of a U.S. investigation related to quality issues involving the manufacture of auto-injectors at the company’s Meridian Medical Technologies site.
Many of the largest U.S. pharmacies and drug distributors do not have Teva Pharmaceutical Industries Ltd.’s generic version of EpiPen five months after the life-saving allergy treatment was approved for sale in the United States, pharmacy chains and a group that tracks drug shortages told Reuters.
About 400 U.S. Food and Drug Administration staffers returned to their posts from furlough, including some food inspectors and support professionals, Commissioner Scott Gottlieb said in a tweet.