SILVER SPRING, Md., May 23, 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 and the Veterans Health Administration announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product … Read more
SILVER SPRING, Md., May 23, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with … Read more
Nalmefene Hydrochloride Product in Nasal Spray Form Provides Additional Tool for Harm Reduction Groups and First Responders SILVER SPRING, Md., May 22, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients … Read more
SILVER SPRING, Md., May 19, 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 announced that the National Academies of Sciences, Engineering, and Medicine (NASEM) will conduct an independent study on challenges in supply, market competition, and regulation of infant … Read more
Agency Continues to Support Innovation of Next-Generation Technology in Diabetes Management SILVER SPRING, Md., May 19, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with … Read more
SILVER SPRING, Md., May 19, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. … Read more
In English SILVER SPRING, Md., 16 de mayo de 2023 /PRNewswire-HISPANIC PR WIRE/– La Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) aprobó Veozah (fezolinetant), un medicamento oral para el tratamiento de síntomas vasomotores moderados a graves, o sofocos, causados por la menopausia. Veozah es el primer antagonista del receptor … Read more
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
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
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