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Drugs and Devices

On August 8, the U.S. Food and Drug Administration (FDA) approved Poteligeo (mogamulizumab-kpkc) injection for IV use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. These are two rare, hard-to . . .

On July 30, the U.S. Food and Drug Administration (FDA) approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that are unresectable, have metastasized, and require systemic anticancer . . .

On July 18, the U.S. Food and Drug Administration (FDA) approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine . . .

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 . . .

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