The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.

Danziten is a twice daily, oral medication that inhibits the BCR-ABL tyrosine kinase. Nilotinib was originally approved under the brand name Tasigna; it is currently indicated for adults and pediatric ...

The Food and Drug Administration (FDA) has expanded the approval of Nerivio ® (Theranica) to include the acute and/or ...

Source: Getty Images “The potential adverse impact of chemotherapy exposure during pregnancy is likely mediated through ...

The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial, as well as real-world evidence.

The detailed results were published in The New England Journal of Medicine and were presented at ObesityWeek 2024.

The Food and Drug Administration (FDA) has granted accelerated approval to Kebilidi™ (eladocagene exuparvovec-tneq) for the treatment of adult and pediatric patients with aromatic L-amino acid ...

Dementia death rates stable between 2018 and 2019, then increased in 2020, and declined in 2022, with the rate higher than 2018, 2019 ...

Catriona Reddin, MB, BCh, from the University of Galway in Ireland, and colleagues examined whether the importance of individual risk factors for stroke differ by stroke severity. Stroke severity was ...

Researchers emulated target trials comparing recurrence of nephrolithiasis among patients with preexisting nephrolithiasis initiating SGLT-2 inhibitors vs an active comparator. (HealthDay News) — For ...

Researchers analyzed whole-genome sequencing data from 76,805 patients to identify variants in 4 genes that are associated ...

In the univariate analysis, those on an SGLT-2i/GLP-1 RA had a reduced risk for mortality, incident MI, and composite.