FDA Approves Evenity

April 9, 2019 — The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are…

FDA Approves Ketamine-Like Drug for Severe Depression

WEDNESDAY, March 6, 2019 — The U.S. Food and Drug Administration on Tuesday approved the nasal spray medication esketamine — a relative of the club drug and anesthetic ketamine — for use against severe depression. Sold as Spravato, the fast-acting drug becomes the first new type of medicine approved in…

Walgreens worst violator in tobacco sales to minors, FDA says

(HealthDay)—Walgreens’ high rate of violations for selling tobacco products to minors has led U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D., to ask for a meeting with the company to discuss the issue. In a statement Thursday, Gottlieb said that he is “deeply disturbed that a single pharmacy chain…

FDA Approves Cablivi for Rare Blood-Clotting Disorder

WEDNESDAY, Feb. 6, 2019 — Cablivi (caplacizumab-yhdp) injection has been approved by the U.S. Food and Drug Administration to treat adults with acquired thrombotic thrombocytopenic purpura (aTTP). “Patients with aTTP endure hours of treatment with daily plasma exchange, which requires being attached to a machine that takes blood out of…

FDA to Resume Inspections of Riskier Foods

TUESDAY, Jan. 15, 2019 — Routine inspections of riskier foods will resume as early as today, the U.S. Food and Drug Administration says. There was a brief halt in inspections of foods such as produce, infant formula, and cheeses due to the partial government shutdown, the Associated Press reported. The…