Articles related to FDA

Although the panel voted 16:1 for the new budesonide + albuterol inhaler in adults, they said the data does not support use in children and they were split on use in adolescents over the age of 12.

Anakinra (Kineret, Sobi) currently approved for rheumatoid arthritis and some rare disorders, was granted an emergency use authorization for a subgroup of COVID-hospitalized patients who are at risk of severe respiratory failure.

This approval was based on findings from the open-label, randomized, multicenter POSEIDON trial, which compared data from two of the study’s three treatment arms. When compared to patients in the other treatment arm, patients in this group had a significantly improved OS, with a median OS of 14 months as opposed to 11.7 months.

Artri King and other products with a similar name were the subject of an FDA analysis that exposed hidden drug ingredients, including corticosteroids (diclofenac and dexamethasone). The FDA sent warning letters to Amazon, Walmart, and Latin Foods Market on October 28, 2022, for distributing various Artri and/or Ortiga unapproved and misbranded drug products. Some of these products may still be available on the market. These products have already been voluntarily recalled by Walmart and Latin Foods Market.

Basimglurant is a highly selective, potent, and cell-penetrant negative allosteric modulator of metabotropic glutamate receptor 5 (mGluR5). Based on the LibraTN trial — a 24-week, prospective, double-blind, randomized-withdrawal, placebo-controlled study of basimglurant for trigeminal neuralgia, FDA has granted the molecule Fast Track designation.

The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously decided on October 28 that there is insufficient evidence to support the claim that the pediatric oncology drug 131-I-omburtamab improves overall survival. A radiolabeled antibody, 131-I-omburtamab was created to treat central nervous system/leptomeningeal (CNS/LM) metastases in pediatric patients with neuroblastoma.