BMS warns about the risk of extramedullary hematopoiesis, a rare complication in which the production of blood cells occurs outside of the bone marrow.
A novel therapy in early development aims to permanently turn off the PCSK9 gene in the liver and lower cholesterol with a one-time treatment. It is being developed for a genetic form of high cholesterol.
Drugs approved with an FDA breakthrough designation can provide value that offsets their higher costs, finds study conducted by Tufts Center for the Evaluation of Value and Risk in Health.
Blue Cross Blue Shield of North Carolina found that uptake of Trikafta was rapid after approval and total cost of care increased 52% despite reductions in hospitalizations and nonpharmacy costs.
NOV03 (perfluorohexyloctane) is a first-in-class eye drop with a novel mechanism of action. If approved it will be the first to address signs and symptoms of dry eye disease.
Under the national vaccine strategy, the U.S. Department of Health and Human Services is expanding access to the monkeypox vaccine, Jynneos, in areas with the highest transmission and need.
Lecanemab is monoclonal antibody that targets beta amyloid to treat mild cognitive impairment. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of Jan. 6, 2023.
The United States has acquired adult and pediatric doses of the COVID-19 vaccine for delivery in early fall in a contract worth $3.2 billion, as well as an additional 150,000 doses of bebtelovimab for about $275 million.