FDA Updates for the Week of Feb. 5, 2024: Review Dates and Advisory Committee Meetings Scheduled
February 10th 2024The FDA has set PDUFA dates for several products: Arexvy to prevent RSV in 50 to the 59 population, for acoramidis in heart failure indication, and for an engineered tissue for vascular replacement. The agency has also scheduled an advisory committee meeting for Abecma in supplemental multiple myeloma indication. Additionally, Amneal has resubmitted its application for novel Parkinson’s therapy.
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10 State Medicaid Programs Include Pheburane for Urea Cycle Disorders
January 23rd 2024Current treatments for urea cycle disorders, which causes ammonia to build up in the blood, have a bitter taste and smell. Pheburane was developed with a special coating that masks the taste of sodium phenylbutyrate. It has a list price of $4,375 per bottle.
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Important Vaccines Approved in 2023, But Vaccine Hesitancy Persists
January 19th 2024Last year saw the approval of several firsts, including the first vaccines to prevent respiratory syncytial virus in older adults and infants and a first vaccine to prevent the mosquito-borne virus chikungunya.
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