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Breaking News by tag «FDA»

Breaking News by tag «FDA»

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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 Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma

The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma.
FDA
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
FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality

The U.S. Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality.
FDA
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic

The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).
FDA
Important Information about Young Donor Plasma Infusions for Profit

The Food and Drug Administration (FDA) is advising consumers to be cautious about establishments offering infusions of plasma obtained from young human donors with the claim that the infused plasma will treat a variety of conditions ranging from normal aging to memory loss.
donor FDA
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
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