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FDA approves imaging drug to help identify lung cancer lesions

The U.S. Food and Drug Administration has approved a new indication for Cytalux (pafolacianine) to assist surgeons in identifying lung cancer lesions in adult patients with known or suspected lung cancer.

FDA
Third member of U.S. FDA advisory panel resigns over Alzheimer’s drug approval

A third member of a panel of outside advisers to the U.S. Food and Drug Administration has resigned in protest over the agency’s decision to approve Biogen Inc’s (BIIB.O) Alzheimer’s disease treatment despite the committee’s recommendation against doing so.
FDA Alzheimer's disease
FDA Authorizes First COVID-19 Test for Self-Testing at Home

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
FDA COVID-19
Statement from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D.

On agency efforts to work with tech industry to spur innovation in digital health

FDA
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

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.
FDA
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma

Yescarta is the second gene therapy product approved in the U.S.
FDA
FDA approval brings first gene therapy to the United States

The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.
FDA
FDA takes several actions involving genetically engineered plants and animals for food

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.
FDA
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