Istituzioni

FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

Agency issued two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications.

FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.

FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines - eszopiclone, zaleplon and zolpidem

FDA has authorized the marketing of new tobacco products manufactured by Phillip Morris Products S.A. for the IQOS “Tobacco Heating System.”

La FDA exige advertencias más estrictas sobre incidentes poco comunes, pero graves, relacionados con ciertas medicinas recetadas para el insomnio: eszopiclona, zaleplón y zolpidem.

FDA announces steps to usher the U.S. into a new era of smarter food safety

FDA approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17.

FDA approves new version of OTC Primatene Mist inhaler to treat mild, intermittent asthma for people who have been diagnosed with asthma by their physician

FDA issues information to industry on advanced pharmaceutical manufacturing

La campaña “Elimine el Riesgo“ va dirigida a mujeres de entre 35 y 64 años de edad, quienes son las más proclives a participar en las decisiones de salud en el hogar, y con frecuencia son las que controlan el acceso de los opioides y otros medicamentos de prescripción médica en el hogar.

The device enables doctors to better assess lungs that were initially deemed to be unsuitable for transplant

FDA approves Benlysta for treatment of children with systemic lupus erythematosus (SLE), a chronic disease causing inflammation and damage to tissue and organs

The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.

FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.

The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.

FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

“Remove the Risk” to raise awareness about proper disposal of prescription opioids