Martes 29 de septiembre de 2026 · 152 publicaciones en las últimas 24 h · 29 fuentes · actualizado hace 20 min
Regulador de medicamentos y alimentos de EE. UU. Autoridad sanitaria · Estados Unidos · Sitio oficial.
20 notas · Solo en español
The U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals.
The U.S. Food and Drug Administration today approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis (excess thyroid hormone levels in the blood that causes symptoms, such as rapid heart rate, increased blood pressure and adverse effects on metabolism) in patient
Medicamentos y regulaciónCardiologíaDiabetes, obesidad y metabolismo
FDA is carefully reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent judicial developments, including a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulatory framework.
A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.
The FDA today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they’re tried in humans.
The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A.
Medicamentos y regulaciónPediatríaInteligencia artificial y tecnología
The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot.
The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN)
The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.
Medicamentos y regulaciónOncologíaSalud de la mujer y embarazo
The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients.
The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar
The U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells.
The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults.
FDA issues Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound.
The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule.
The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes.
Medicamentos y regulaciónNutrición y hábitosInteligencia artificial y tecnología
The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) as the first-ever treatment for adults and children 8 years of age and older with glycogen storage disease type Ia (GSDIa)
Medicamentos y regulaciónInteligencia artificial y tecnología
The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention.
Medicamentos y regulaciónInteligencia artificial y tecnología
The U.S. Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics
Medicamentos y regulaciónInteligencia artificial y tecnología
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