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This week, the FDA granted full approval to the Alzheimer’s drug Leqembi, set an action for review of zolbetuximab to treat gastric cancers and rejected Amneal’s new drug application (NDA) Parkinson’s disease treatment.

In this population-based cohort study, researchers compared the risks of incident cardiovascular, neurological, and mental health conditions and rheumatoid arthritis in a year following COVID hospitalization to three different groups: pre-pandemic hospitalization for influenza, pre-pandemic hospitalization for sepsis and hospitalization for sepsis post-pandemic.

Approvals this week include: a $2.9 million gene therapy for hemophilia A; a pediatric growth hormone; the first cell therapy for type 1 diabetes; a new alopecia drug; a therapy for generalized myasthenia gravis; and full approval for Blincyto in B-cell ALL. The agency also rejected a higher dose of Eylea and set an action for hemophilia B gene therapy.

The FDA’s approvals this week include: a $3.2 million gene therapy, the first anti-inflammatory drug for cardiovascular disease, a subcutaneous version of Vyvgart for myasthenia gravis and Jardiance and Synjardy for kids with type 2 diabetes. Three rejections by the agency include: a therapy for NASH, for retinal cancer, and for rare fungal infections. In addition, Geron has submitted an NDA for first-in-class therapy for MDS.