Tag: Food & Drug Administration
FDA Approves Imbruvica for Pediatric Chronic Graft Versus Host Disease
Approval is for chronic disease after failure of one or more lines of systemic therapy
FDA Approves First Cell-Based Gene Therapy for Beta-Thalassemia
The single-dose treatment is approved for transfusion-dependent adults and children
Tabrecta Gains Full FDA Approval for Non-Small Cell Lung Cancer
Drug approved for non-small cell lung cancer with mutation leading to MET exon 14 skipping
FDA Warns Amazon, Other Vendors About Sale of Skin Tag Removal Products
No over-the-counter medications have FDA approval for the removal of moles and skin tags
FDA Drafts Guidance on Patient Labeling Information for LASIK Devices
Guidance offers content and formatting suggestions for patient information for laser-assisted in situ keratomileusis devices
Supplement Manufacturers Often Ignore FDA Warning Letters
Twenty-nine percent of products targeted in FDA warning letters remained available for purchase online at a mean of six years later
FDA to Take a Hard Look at Its Food, Tobacco Programs
Agency has been under heightened scrutiny since the nationwide infant formula shortage and debate over e-cigarette products
FDA Temporarily Suspends Ban on Juul E-Cigarettes
To remain on the market, e-cigarette manufacturers must prove there is a public health benefit with their use
FDA Tells Vaccine Makers to Update Boosters to Target Omicron Subvariants
Pfizer and Moderna are expected to start producing reformulated doses this summer
FDA Panel to Weigh Improved Booster Shots From Moderna, Pfizer
Both Pfizer and Moderna have been testing updated booster shots that target the omicron variant
