U.S. Food and Drug Administration

FDA Roundup: May 12, 2023

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SILVER SPRING, Md., May 12, 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 updated information on medical device shortages on the FDA.gov website to reflect the end of the COVID-19 public health emergency (PHE), including providing answers to questions, … Read more

FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

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SILVER SPRING, Md., May 12, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes … Read more

La FDA aprueba el primer medicamento para tratar los síntomas de agitación asociados con la demencia debida a la enfermedad de Alzheimer

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In English SILVER SPRING, Md., 11 de mayo de 2023 /PRNewswire-HISPANIC PR WIRE/ — Hoy, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) otorgó la aprobación complementaria para los comprimidos orales de Rexulti (brexpiprazol) para el tratamiento de la agitación asociada con la demencia debido a la enfermedad de Alzheimer. … Read more

La FDA finaliza la transición para recomendar una evaluación de riesgos individual a fin de determinar la elegibilidad para donaciones de sangre

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In English  SILVER SPRING, Md., 11 de mayo de 2023 /PRNewswire-HISPANIC PR WIRE/ — Hoy, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) finalizó las recomendaciones para evaluar la elegibilidad de los donantes de sangre mediante un conjunto de preguntas individuales basadas en el riesgo para reducir el riesgo … Read more

FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease

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SILVER SPRING, Md., May 11, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication. “Agitation is one of the most common and challenging aspects … Read more

FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations

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SILVER SPRING, Md., May 11, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may … Read more