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FDA encouraged the Company to accelerate enrollment of adolescent patients due to Piclidenoson’s good safety profile There is an unmet need for safe, convenient, and effective drugs to treat...
Topline results from pivotal Phase 3 study of uproleselan in relapsed/refractory Acute Myeloid Leukemia on track to be reported by end of Q2 2024 NDA filing for uproleselan anticipated by end...
On May 17, the U.S. Food & Drug Administration ("FDA") issued two important draft guidance documents, which clarify the agency's approach to requirements and incentives in the realm of pediatric drug development...
On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of...
FDA issued two new guidances on development and clinical trials of pediatric medications replacing 2005 rules. Pediatric drugs are developed slower difficulty clinical testing. Adult drugs can be used off label for children. New rules incentivize pediatric drug development.