Da Hee Han, PharmD

Andexxa was initially granted accelerated approval in May 2018 for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation was needed due to life-threatening or uncontrolled bleeding.

The sNDA submission was supported by Phase 3 data from the MAGELLAN and MARINER trials which assessed the use of rivaroxaban in preventing VTE in acute medically ill patients while hospitalized and immediately after discharge.

A study published in Circulation has found a reduced risk of cardiovascular (CV) death in heart failure patients when they are given routine influenza vaccinations.

Currently, same-day delivery is available only in Dallas, Chicago, New York City, Gainesville, Miami, Tampa, and Fort Lauderdale; this program will be expanded in 2019.

The FDA has issued a warning regarding rare cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection in patients with MS shortly after receiving Lemtrada.

The guidelines were developed by over 100 experts, including hematologists, patient representatives, and other specialists.

This guidance, updated for the first time since 2008, provides evidence-based recommendations for children (ages 3-17) and adults.

Low-dose methotrexate did not result in a reduced number of cardiovascular events among patients with stable atherosclerosis.

The risk for the primary composite endpoint was significantly lowered by 25% among patients who received 2g of icosapent ethyl twice daily vs those who received placebo.

Sandoz announced a voluntary recall of 1 lot of Losartan Potassium and Hydrochlorothiazide Tablets 100mg/25mg due to trace amounts of NDEA found in the API losartan.