The European Commission has approved Venclyxto in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia, who were previously untreated.
FDA has approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
FDA has granted an investigational CD30-directed autologous chimeric antigen receptor T cell (CD30 CAR-T) therapy Regenerative Medicine Advanced Therapy designation for treatment of patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma.
FDA has granted Fast Track designation to tipifarnib for the treatment of adult patients with relapsed or refractory angioimmunoblastic T-cell lymphoma (AITL), follicular T-cell lymphoma and nodal peripheral T-cell lymphoma with T follicular helper (TFH) phenotype.
Thermo Fisher Scientific Inc. has acquired Qiagen, a molecular diagnostics and sample preparation technology provider.
FDA approved neratinib Feb. 25 in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
FDA has accepted a supplemental new drug application for Zejula (niraparib) as maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.
FDA has granted Tessa Therapeutics investigational CD30-directed autologous chimeric antigen receptor T cell therapy Regenerative Medicine Advanced Therapy for relapsed or refractory CD30-positive classical Hodgkin lymphoma.
A Feb. 21 Personalized Medicine Coalition report says 12 personalized treatments and seven diagnostics approved or cleared by FDA in 2019 will improve patient care and address root causes of rare diseases, expand treatment for cancer patients, and target therapies to people who respond.
Boehringer Ingelheim and Trutino Biosciences entered into a licensing agreement based on Trutino's innovative On-Demand-Cytokine platform.
