Articles related to FDA

NeuroStar is the first FDA-approved transcranial magnetic stimulation (TMS) system developed to treat major depressive disorders. With the new FDA approval, this TMS system will allow physicians to better treat patients with obsessive compulsive disorder (OCD) without the need for additional hardware.

An FDA expert panel voted 16-0, with one abstention, recommending that future FDA approvals of PI3K inhibitors be supported by randomized data. The four currently-approved PI3K inhibitors for treating hematologic malignancies received FDA approval based on single-arm data. Although these drugs have offered durable ORR and improvements in PFS, randomized data presented at the hearing showed they are associated with higher rates of serious adverse events, including fatality.

The US Food and Drug Administration (FDA) has said “no” to Akebia Therapeutics’ drug application for vadadustat, a therapy to treat anemia due to chronic kidney disease. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. The FDA cited safety concerns as the main reason for it rejecting the application.

The FDA has withdrawn its authorization for use of the monoclonal antibody sotrovimab in the treatment of COVID-19 in regions with a high frequency of the Omicron BA.2 subvariant. Data show that the authorized dose of the monoclonal antibody — 500 mg — is unlikely to be effective against the BA.2 COVID-19 subvariant.

The FDA has issued a warning that transmucosal buprenorphine products may cause tooth decay, cavities, oral infections, and tooth loss. The federal agency said it has identified 305 cases of dental problems that were associated with buprenorphine tablets and films that dissolve under the tongue or against the inside of the cheek.

Orexin receptor antagonists work by suppressing the wake drive through blocking wake-promoting neuropeptides. Daridorexant is the third dual-orexin inhibitor to receive FDA approval for people with difficulty in sleep onset or sleep maintenance.