Socioeconomic Status Is the Biggest Reason Women Don’t Get Breast Cancer Screening
March 5th 2024Women experiencing high levels of poverty and those in impoverished rural regions are less likely to get screened for breast cancer, find a new review of studies that have assessed social determinants of health.
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FDA has expanded the indication for Biktarvy for those with resistant HIV, granted full approval to Rybrevant and approved Simlandi, the third interchangeable Humira biosimilar. The regulatory agency has also set action dates for sxatilimab in graft-versus-host disease, tislelizumab in stomach cancer and a second indication for Epkinly.
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FDA Updates for the Week of Feb 19: Cancer Approval Revoked
February 24th 2024The FDA has removed the approval of Pepaxto in multiple myeloma. The agency approved Amtagvi, the first TIL therapy for a solid tumor, as well a new biweekly dosing of Tecvayli for multiple myeloma. The agency has set actions for several products, including a first-in-class lung cancer therapy, a bispecific antibody for advanced multiple myeloma, and another for Dupixent for COPD
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FDA Updates for the Week of Feb. 12, 2024: New Approvals, an Extended Review and Goal Dates Set
February 17th 2024The FDA approves Eohilia for eosinophilic esophagitis and Onivyde for metastatic pancreatic cancer but extends review of gene therapy for rare immune disorder. The agency also set goal dates for three products: full approval for Elevidys, Augtyro for solid tumors with NTRK gene fusions and seladelpar as for rare liver disease.
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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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FDA Updates for the Week of Nov. 20, 2023
November 25th 2023FDA has approved a new therapy for HR positive breast cancer and announces plan to hold advisory meeting for Abecma in earlier treatment of multiple myeloma. In addition, Janssen has submitted a supplemental application for Rybrevant in NSCLC.
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