SILVER SPRING, Md., June 6, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of … Read more
Agency Requesting Feedback on the Draft Recommendations and How They Should Be Applied to Increasingly Diverse Trial Types and Data Sources SILVER SPRING, Md., June 6, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the … Read more
SILVER SPRING, Md., June 2, 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 an update on medical device reports it received that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used … Read more
SILVER SPRING, Md., May 30, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA published the FDA Voices: “How FDA’s New Approach to Reviewing Chemicals Added to Food Will Strengthen Food Safety,” by Robert M. Califf, M.D., Commissioner of … Read more
SILVER SPRING, Md., May 26, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued warning letters to firms responsible for two popular flavored, disposable e-cigarette products—Shenzen Innokin Technology Co. Ltd., who make Esco Bars products, and Breeze Smoke … Read more
In English SILVER SPRING, Md., 26 de mayo de 2023 /PRNewswire-HISPANIC PR WIRE/ — La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó el antiviral de ingestión oral Paxlovid (tabletas de nirmatrelvir y tabletas de ritonavir, empaquetadas conjuntamente para administrarse por vía oral) para el tratamiento del … Read more
SILVER SPRING, Md., May 25, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth … Read more
In English SILVER SPRING, Md., 24 de mayo de 2023 /PRNewswire-HISPANIC PR WIRE/ — La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó la inyección subcutánea (para uso por debajo de la piel) de Brixadi (buprenorfina) de liberación prolongada para tratar el trastorno por consumo de opioides … Read more
In English SILVER SPRING, Md., 24 de mayo de 2023 /PRNewswire-HISPANIC PR WIRE/ — La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó Xacduro (sulbactam inyectable; durlobactam inyectable), un nuevo tratamiento para la neumonía bacteriana adquirida en el hospital (HABP, por sus siglas en inglés) y la … Read more
SILVER SPRING, Md., May 23, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. According … Read more