Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
A new dosing regimen for Turalio® (pexidartinib) is now available for the treatment of adults with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The recommended dose of Turalio is now 250mg orally twice daily (taken as two 125mg capsules) with a low-fat meal…
Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently.
AT-GAA consists of cipaglucosidase alfa administered in conjunction with miglustat.
The Amulet device is designed for complete immediate closure of the left atrial appendage using dual-seal technology.
Olezarsen is an investigational LICA antisense medication designed to inhibit the production of apoC-III for patients at risk of disease due to elevated triglyceride levels.
Under the FDA’s orders, the Company may not market or distribute these products in the US.
The sNDA is supported by data from the phase 2 PIONEER trial that evaluated the efficacy and safety of avapritinib in patients with indolent systemic mastocytosis.
In patients whose tumors had ESR1 mutations, elacestrant reduced the risk of progression or death by 45%.
The approval was based on data from the phase 1/2 ZUMA-3 trial which evaluated Tecartus in 71 adults with relapsed or refractory B-cell precursor ALL.
