FDA granted priority review for MCNA, developed by Telesta Therapeutics Inc.
FDA granted Orphan Drug Designation for MTG-201, a therapy targeting Dickkopf-3 gene defects in various cancers, for the treatment of malignant mesothelioma.
FDA granted Orphan Drug Designation to Toca 511 & Toca FC, an investigational immunotherapy treatment for glioblastoma developed by Tocagen.
The European Commission granted a marketing authorization for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation.
The European Commission granted a marketing authorization for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation. Unituxin is administered in combination with granulocyte-macrophage colony-stimulating factor,... […]
Mirati Therapeutics Inc. and MedImmune, the global biologics research and development arm of AstraZeneca, announced they have entered into an exclusive clinical trial collaboration.
AstraZeneca and Heptares Therapeutics entered into a licensing agreement under which AstraZeneca will acquire exclusive global rights to develop, manufacture and commercialize the adenosine A2A receptor antagonist HTL-1071, a small molecule immuno-oncology candidate.
The European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products, granted orphan drug designation to synthetic hypericin, the active pharmaceutical ingredient in SGX301, for the treatment of cutaneous T-cell lymphoma, a rare disease and a class of non-Hodgkin's lymphoma.
Health Canada issued a Notice of Compliance with Conditions for Imbruvica (ibrutinib) an oral, once-daily single-agent therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma.
FDA approved Odomzo (sonidegib) capsules for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Odomzo is marketed by Novartis Pharmaceuticals Corp.
