U.S. Food and Drug Administration

In English  SILVER SPRING, Md., 22 de junio de 2023 /PRNewswire-HISPANIC PR WIRE/ — Hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó Jardiance (empagliflozina) y Synjardy (empagliflozina y clorhidrato de metformina) como adiciones a la dieta y el ejercicio para mejorar el control del azúcar en … Read more

SILVER SPRING, Md., June 22, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing medical reason preventing treatment with … Read more

Calls to Poison Centers About Elf Bar Exposure Among Children Under 5 Raise Concerns SILVER SPRING, Md., June 22, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is announcing it has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both brands are disposable … Read more

SILVER SPRING, Md., June 20, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of medicines taken by mouth … Read more

SILVER SPRING, Md., June 20, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA released its report on the Occurrence of Foodborne Illness Risk Factors in Fast Food and Full-service Restaurants. According to the Centers for Disease Control and Prevention (CDC) … Read more

Pilot Geared Toward Sponsors of Certain Oncology Drug Products Used with Certain In Vitro Diagnostic Tests to Identify Patients for Certain Cancer Treatments SILVER SPRING, Md., June 20, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro … Read more

SILVER SPRING, Md., June 13, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA published the FDA Voices: “Accelerating Rare disease Cures (ARC) Program Emerges as a Conduit for Empowering Rare Disease Stakeholders,” by Kerry Jo Lee, M.D., Associate Director for … Read more

SILVER SPRING, Md., June 9, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA provided information to health care providers and facilities on oxygenator devices used in extracorporeal circulation. The FDA issued this letter to help ensure that health care … Read more

SILVER SPRING, Md., June 6, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, the FDA issued a Letter to Health Care Providers recommending health care facilities and health care providers implement conservation strategies for non-sterile, single-use pneumatic tourniquet cuffs in … Read more