FDA clearance
Eisai, Biogen's Leqembi Receives FDA Approval for Chronic Alzheimer's Maintenance Treatment
With this approval, patients who receive the anti-amyloid drug biweekly for 18 months can then consider switching to a monthly dosing regimen.
FDA Approves New 'Vanza Triple' Cystic Fibrosis Drug From Vertex, Expands Label for Trikafta
Alyftrek is approved as a new treatment for cystic fibrosis, while the FDA expanded the label for Trikafta to include additional genetic mutations.
PTC Therapeutics' AADC Deficiency Gene Therapy Kebilidi Gains FDA Accelerated Approval
This is the first gene therapy for AADC deficiency to receive US regulatory approval and the first that can be administered directly to the brain.
FDA Approves Autolus' CAR T-Cell Therapy Aucatzyl for B-Cell Acute Lymphoblastic Leukemia
The agency reviewed data from the FELIX trial, in which 63 percent of patients achieved a complete remission on the cell therapy at any time point.
FDA Approves Thermo Fisher Oncomine Dx Target Test as CDx for Servier's Voranigo Brain Cancer Drug
The approval expands the clinical indications for the test, which was previously approved as a CDx for non-small cell lung cancer, thyroid cancer, and bile duct cancer drugs.