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Drugs and Devices

Insurance denial rates for direct-acting antiviral drugs used to treat hepatitis C are high—more than 50% for those with private insurance—according to a study in Open Forum Infectious Diseases. The drugs have been a game-changer in saving patients lives.

Read more via Penn Medicine News and . . .

On June 4, the U.S. Food and Drug Administration (FDA) approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence . . .

People with a family history of alcohol use disorder (AUD) release more dopamine in the brain’s main reward center in response to the expectation of alcohol than people diagnosed with the disorder, or healthy people without any family history of AUD, according to a study in Biological Psychiatry: Cognitive . . .

On May 11, the U.S. Food and Drug Administration (FDA) approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first drug FDA has approved for treating MS in pediatric patients.

Read more via FDA.gov . . .

On May 15, the U.S. Food and Drug Administration (FDA) approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.

Read more via FDA.gov . . .

A study in Frontiers in Immunology reports that the vaccination rate needed to establish group immunity (80%) to the Ebola virus isn’t realistic and for the foreseeable future, outbreak management will depend on surveillance and case isolation.

Read more via Frontiersin.org . . .

On April 17, the U.S. Food and Drug Administration (FDA) approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia, a rare, inherited form of rickets.

Read more via FDA . . .

A study in the American Journal of Critical Care finds that compared to an earlier survey, almost twice as many clinicians report that their hospitals have experience adverse events related to alarms in the past 2 years, although there has been a significant increase in alarm improvement initiatives over the . . .

On April 11, the U.S. Food and Drug Administration (FDA) cleared IDx-DR, the first medical device to use artificial intelligence (AI) to detect greater-than-mild level of diabetic retinopathy. IDx-DR is a software program that uses an AI algorithm to analyze images of the eye taken . . .

On March 29, the U.S. Food and Drug Administration (FDA) approved Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease.

Read more via FDA.gov . . .

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