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.
FDA has granted Priority Review to capmatinib's (INC280) New Drug Application.
FDA has granted Breakthrough Therapy designation for Padcevtm in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.
FDA has accepted the Biologics License Application of valoctocogene roxaparvovec for Priority Review.
