FDA approved Imlygic (talimogene laherparepvec) as the first oncolytic viral therapy in the U.S.
FDA granted Priority Review for defibrotide for the treatment of patients with hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, with evidence of multi-organ dysfunction following hematopoietic stem-cell transplantation. FDA review of the new drug application is expected to be completed by March 31, 2016. The application, submitted by Jazz Pharmaceuticals plc, includes safety... […]
FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The agency previously granted Priority Review and orphan drug designations for Onivyde. The effectiveness of Onivyde was demonstrated in a phase III, three-arm, randomized, open label study of... […]
FDA granted Priority Review to MCNA, developed by Telesta, for the treatment of high-risk, non-muscle invasive bladder cancer patients who are refractory or relapsing from BCG front-line treatment.
Imbruvica was awarded the prestigious Prix Galien 2015 Award for Best Pharmaceutical Agent.
FDA approved Imlygic (talimogene laherparepvec) as the first oncolytic viral therapy in the U.S.
FDA granted de novo clearance to SonaCare Medical LLC to market the Sonablate 450 in the U.S. for the ablation of prostate tissue.
FDA approved Yondelis (trabectedin) for the treatment of liposarcoma and leiomyosarcoma that cannot be removed by surgery or is metastatic. This treatment is approved for patients who previously received chemotherapy that contained anthracycline.
FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The agency previously granted Priority Review and orphan drug designations for Onivyde.
Sequenom Inc. entered into a clinical collaboration with University Medical Center Hamburg-Eppendorf in Germany. They will collaborate to profile circulating cell-free tumor DNA in blood to monitor response to treatment in later stage colorectal cancer patients.
