FDA granted accelerated approval to Genentech's Tecentriq (atezolizumab) for the initial treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.
FDA granted Breakthrough Therapy designation to Novartis's CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma who have failed two or more prior therapies.
Health Canada approved via priority review Janssen's Darzalex (daratumumab), in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
FDA has removed the Risk Evaluation and Mitigation Strategy requirements for erythropoiesis-stimulating agents in patients with anemia due to associated myelo-suppressive chemotherapy.
The Human Vaccines Project, Vanderbilt University Medical Center and Illumina Inc. are collaborating on a project focused on deciphering the human immunome, the genetic underpinnings of the immune system.
Oncora Medical, a precision radiation oncology software company, and MD Anderson Cancer Center announced a strategic alliance focusing on building the next generation of precision medicine software for radiation oncology. During phase I, MD Anderson oncologists and information technology professionals will work with Oncora’s team of data scientists and engineers to install Oncora’s Precision Radiation […]
Novartis said the European Commission has approved Tafinlar(dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer.
Janssen Research & Development, LLC said FDA has accepted for review a supplemental New Drug Application for ibrutinib (Imbruvica) for the treatment of patients with chronic graft-versus-host-disease after failure of one or more lines of systemic therapy.
Amgen announced the submission of a supplemental Biologics License Application to FDA and the European Medicines Agency for XGEVA (denosumab).
RedHill Biopharma Ltd., a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, said FDA has granted Yeliva (ABC294640) Orphan Drug designation for the treatment of cholangiocarcinoma.
