News & Updates

New drug applications approved by US FDA as of 16-31 October 2023 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Selpercatinib, a highly selective and potent RET inhibitor, trumped two multikinase inhibitors (MKIs) – cabozantinib and vandetanib – for the treatment of advanced, kinase inhibitor-naïve, RET-mutant medullary thyroid cancer (MTC) in the first-line (1L) setting, according to the interim analysis results of the phase III LIBRETTO-531 trial.

Use of apixaban appears to reduce the risk of gastrointestinal haemorrhage (GIH) compared with dabigatran, rivaroxaban, and vitamin K antagonist (VKA) in patients with nonvalvular atrial fibrillation, a recent study has shown. On the other hand, rivaroxaban use tends to increase GIH risk relative to dabigatran and VKA.