|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.