Michigan is First Medicaid Program to Offer Lyfgenia for Sickle Cell
March 11th 2024Michigan’s state Medicaid agency has signed an outcomes-based agreement for Lyfgenia patients with sickle cell disease. The agreement provides payers with risk sharing tied to vaso-occlusive events-related hospitalizations
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Oral Drug for Hidradenitis Suppurativa Shows Promise in Small Study | AAD 2024
March 9th 2024A phase 2 study demonstrated positive results for remibrutinib, a BTK inhibitor, as a treatment for patients with the rare skin condition, hidradenitis suppurativa, finds a study presented at the American Academy of Dermatology Association.
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FDA Updates for Week of March 4, 2024: Wegovy Gets New Indication
March 9th 2024The FDA has approved Wegovy for reducing cardiovascular risks in people who are obese or overweights. The agency approved new biosimilars that reference Actema, Prolia and Xgeva. Additionally, the FDA plans to hold advisory committee meeting for donanemab in Alzheimer’s disease.
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Opzelura Provides Benefit in Atopic Dermatitis in Real-World Studies | AAD 2024
March 8th 2024Physicians switch to Opzelura (ruxolitinib) when other therapies fail to help patients with atopic dermatitis, according to a new analysis presented at the annual meeting of the American Academy of Dermatology.
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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 Sets Date for Full Approval, Broader Indication for Elevidys
February 16th 2024The FDA has set a PDUFA date of June 21, 2024, to convert the accelerated approval to full approval and expand the labeling of the gene therapy Elevidys beyond the current use in children aged 4 and 5 with Duchenne muscular dystrophy.
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