FDA Approves Adzynma for Rare Blood Clotting Disorder cTTP
November 27th 2023CTTP is rare hereditary blood clotting disorder stemming from a disease-causing mutation in the ADAMTS13 gene. This gene plays a crucial role in producing the ADAMTS13 enzyme, responsible for regulating blood clotting.
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Medicare Part D Premiums Expected to Rise Ahead of Lower IRA Cap on High Drug Costs
November 20th 2023Although the CDC predicted a decline in basic Medicare Part D premiums for 2024 due to the IRA, a recent report revealed an increase in premiums for Medicare Part D prescription drug plans in California, Florida, New York, Pennsylvania and Texas.
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Takeda to Withdraw Oncology Drug Exkivity from U.S. Market
October 2nd 2023In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.
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Enrollment in Early Phase Trial of HIV Vaccine That Uses a Cytomegalovirus Vector Is Underway
September 21st 2023Early results are expected late next year from the phase 1 trial, which is being funded by the National Institute of Allergy and Infecious Diseases, the Bill & Melinda Gates Foundation and Vir Biotechnology, a San Franciso biotech company focused on vaccines and infectious disease.
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FDA Sets Review Date for Resmetirom to Treat Patients with NASH
September 13th 2023The FDA has granted priority review and assigned a Prescription Drug User Fee Act date of March 14, 2024, for resmetirom to treat adult patients with nonalcoholic steatohepatitis (NASH) who have liver fibrosis.
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