SPOTLIGHT -
Recommendations for approval, approvable designations, Fast-track designations
FDA Approves Breyanzi for Follicular Lymphoma
Breyanzi is now included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a recommendation for third-line therapy for relapsed or refractory follicular lymphoma.
Biogen, Eisai Begin Submission of Subcutaneous Leqembi
If approved, the Leqembi autoinjector could be used to administer the treatment for Alzheimer’s disease at home or at medical facilities.
FDA Sets Review Date for Gene Therapy for Enzyme Deficiency
Upstaza is a one-time gene therapy to treat patients 18 months and older with AADC deficiency. It has a review date of Nov. 13, 2024.
Boehringer Ingelheim is Second Company to Provide Private-Label Humira Biosimilar to Evernorth
Boehringer Ingelheim also received FDA approval for a high-concentration formulation of Cyltezo, its branded Humira biosimilar.
Administrative Issues Delay FDA Decision on Moderna RSV Vaccine
Regulators are now working to complete their review of the BLA for mRNA-1345 by the end of May 2024. mRNA-1345 to be reviewed at the CDC's Advisory Committee on Immunization Practices in June 2024.
KFF: 1 in 8 Adults have Used GLP-1 Agonists
New KFF poll finds most of the adults who have taken GLP-1 therapies have diabetes or heart disease. But 38% said they have used for these drugs solely to lose weight.