Denise Myshko

Articles by Denise Myshko

The 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.

The 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.

Christian Delbert-stock.adobe.com

Two new studies look at the financial hardships faced by those with a cancer diagnosis. Authors of both suggest there is a need for improving health insurance coverage.

This week, the FDA has approved several products, including Beqvez, the second gene therapy hemophilia B; Ojemda for children with brain tumors; an additional indication for Lutathera for adolescents with neuroendocrine tumors; and a bladder cancer immunotherapy. The agency has also issued a complete response letter for pz-cel to treat epidermolysis bullosa.