FDA gives de novo premarket approval to Luminopia One to use a virtual reality headset to treat amblyopia, or lazy eye, in children ages 4-7.
FDA puts a clinical hold on an AstraZeneca trial of an investigational blood cancer drug after heart concerns were reported in one patient.
Merck recalls one lot of Cubicin (daptomycin for injection) 500mg for intravenous use due to a complaint being received about a piece of glass found i...
FDA approves Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) as an add-on maintenance treatment for certain patients aged six to 11 years w...
FDA approves an Esteve Pharmaceuticals NDA for Seglentis (celecoxib and tramadol hydrochloride) for treating acute pain in adults.
CDCs Advisory Committee for Immunization Practices votes to recommend accepting FDAs 10/20 amended emergency use authorizations for booster doses of b...
FDA denies a Stryker Medical petition seeking a premarket notification exemption for some powered patient transport devices.
Bryant Ranch Prepack recalls one lot of methocarbamol 500mg tablets due to a mislabeling error.