On agency efforts to work with tech industry to spur innovation in digital health
The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
Yescarta is the second gene therapy product approved in the U.S.
The U. S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed.
Based on sound science and a comprehensive review, the U.S. Food and Drug Administration is taking several important steps today regarding food from genetically engineered (GE) plants and animals, including the first approval for a genetically engineered animal intended for food, AquAdvantage Salmon. The agency is also issuing two guidances for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources: a draft guidance on labeling foods derived from Atlantic salmon, and a final guidance on foods derived from GE plants.
Patients with advanced pancreatic cancer now have access to the new FDA approved drug, Onivyde, that produced significant overall survival rates in an international clinical study conducted in part by researchers at HonorHealth Research Institute and the Translational Genomics Research Institute (TGen).
Shares of Edwards Lifesciences Corp. jumped after U.S. regulators approved a newer, thinner version of the company’s artificial heart valve. The stock rose 2.9 percent to $141.96 at 3:43 p.m. in New York. The shares had risen 8.3 percent this year through Tuesday.