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Inotuzumab ozogamicin moves to the head of the line
Company abused government processes to delay generic competition, agency contends
Phase 3 trial examines one-time angiogenic treatment
Decision based on positive phase 2 data
Pivotal trials support efficacy of ceftazidime/avibactam in UTIs
Some patients required hospitalization
Two-milligram formulation green-lighted for emergency use
Anti–IL-6 receptor biologic is indicated for rheumatoid arthritis
Agency seeks comments on draft guidelines