Recent FDA action (through July 2009) related to bucindolol, botulinum toxin type A, rivaroxaban, quetiapine, olanzapine, ziprasidone, ofatumumab, pegloticase, pralatrexate, melphalan, and paclitaxel
Complete response
Recommended for approval
Fast-track designations
Orphan drug designations
FDA Approves Pfizer’s Gene Therapy for Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.