Company Product Description Indication Status
Amgen Inc., of Thousand Oaks, Calif., and UCB SA, of Brussels Evenity (romosozumab) Sclerostin inhibitor Osteoporosis European Commission granted marketing authorization to treat severe disease in postmenopausal women at high risk of fracture
Astrazeneca plc, of Cambridge, U.K. Imfinzi (durvalumab) PD-L1 inhibitor Non-small-cell lung cancer China’s NMPA granted approval to treat unresectable, stage III disease that did not progress following concurrent platinum-based chemotherapy and radiation therapy
Kite, a unit of Gilead Sciences Inc., of Foster City, Calif. KTE-X19 CAR-T cell therapy Mantle cell lymphoma Submitted BLA to FDA for treatment of adults with relapsed/refractory disease
Provention Bio Inc., of Oldwick, N.J. PRV-031 (teplizumab) CD3 antagonist Type 1 diabetes (T1D) Following receipt of minutes from type B meeting with FDA to discuss BLA for prevention or delay of T1D in at-risk individuals, rolling BLA submission expected to begin in mid-2020 with completion targeted for fourth quarter of 2020; no additional trials in at-risk population expected prior to submission
Y-Mabs Therapeutics Inc., of New York GD2-GD3 (MV-NB-02) Bivalent ganglioside vaccine targeting GD2-/GD3-lactone  Neuroblastoma FDA granted rare pediatric disease designation in the indication


For more information about individual companies and/or products, see Cortellis.

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