US FDA

Spark Therapeutics and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies' SPK-FIX program, in development for the treatment of hemophilia B. SPK-9001, a novel bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized, high-activity human factor IX variant, is being investigated in an ongoing Phase 1/2 trial as a potential one-time therapy.

Relievant Medsystems, Inc., a privately held medical device company pioneering the therapy of nerve ablation within vertebral bodies for the treatment of chronic low back pain, announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the INTRACEPT® Intraosseous Nerve Ablation System.

CytoDyn Inc. announces that it has submitted to the U.S. Food And Drug Administration (FDA) an application for orphan drug designation for the use of PRO 140 (humanized monoclonal antibody to CCR5) in the pretreatment of HIV Type-1 (HIV-1) infection in treatment-naïve adults while they are waiting for drug resistance assay results to construct a subsequent Highly Active Antiretroviral Therapy (HAART) regimen.  The generation of these assay results typically takes approximately two weeks.

Advaxis, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), as a Fast Track product for adjuvant therapy for high-risk locally advanced cervical cancer patients. The investigation of AXAL in this under-served population will be conducted in accordance with the Special Protocol Assessment (SPA) recently granted by the FDA.