FDA Updates for Week of May 27: 2 Approvals including New Biosimilar
June 1st 2024The FDA has made two approvals this week: the first interchangeable biosimilar of Soliris and another indication for Breyanzi for mantle cell lymphoma. The agency has delay a decision on Dupixent in COPD and has set goal dates for zolbetuximab in gastric cancer and zanidatamab in bile duct cancer.
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Medicare Patients Under 65 with PAH Face High Burden and Costs | 2024 ATS
May 19th 2024Medicare patients under 65 who have pulmonary arterial hypertension require prolonged disability insurance and have found to have high healthcare costs, while further disparities are seen for those that face additional financial hardships, according to a poster at the annual ATS meeting.
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FDA Updates for Week of May 13: First Bispecific Antibody for Solid Tumor
May 18th 2024The FDA has approved a new type of bispecific antibody to treat small cell lung cancer and an additional indication for Breyanzi for patients with follicular lymphoma. The agency has set review date for gene therapy for enzyme deficiency. In addition, Biogen have Eisai hve begun a rolling submission of subcutaneous Leqembi for Alzheimer’s disease.
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FDA Updates for the Week of May 6: An Approval, a Delay and Two Ad Comm Meetings
May 11th 2024The FDA has approved a liquid mycophenolate to prevent organ rejections but delayed the approval of Moderna’s RSV vaccine. Regulators have set dates for advisory committee meetings for midomafetamine for PTSD and for donanemab in Alzheimer’s disease. Additionally, the agency has set review dates for a subcutaneous Opdivo and a pancreatic/lung cancer therapy.
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FDA Updates for Week of April 29, 2024: Full Approval for Tivdak
May 4th 2024The FDA made several approvals this week, including converting Tivdak’s accelerated approval to full approval for cervical cancer and approvals for a high-concentration formulation of Cyltezo, Xolremdi for an ultra rare immune disorder and Libervant Film for epilepsy in young children.
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