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.
FDA has granted approval Pemfexy, a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin and other indications.
Bristol-Myers Squibb Co. said FDA has accepted for Priority Review its Biologics License Application for lisocabtagene maraleucel (liso-cel), the company's autologous anti-CD19 CAR T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The FDA has set a Prescription Drug User Fee Act goal date of Aug. 17.
FDA has accepted Seattle Genetics' new drug application for its investigational medicine tucatinib for Priority Review.
