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December 28, 2023
On Tuesday, Cingulate Inc (NASDAQ: CING) received FDA guidance f
December 5, 2023
/PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced it received Breakthrough Therapy designation from the U.S. Food and Drug...
October 5, 2023
(RTTNews) - Neurocrine Biosciences, Inc. (NBIX) reported positive top-line data from the Phase 3 CAHtalyst Pediatric Study evaluating the efficacy...
October 5, 2023
Neurocrine Biosciences Inc (NASDAQ: NBIX) released topline data from the Phase 3 CAHtalyst Pediatric Study of crinecerfont in children and adolescents with classic congenital adrenal hyperplasia (CAH) due to 
October 5, 2023
Neurocrine Biosciences Inc NBIX released topline data from the Phase 3 CAHtalyst Pediatric Study of crinecerfont in children and adolescents with classic…
September 21, 2023
/PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced that it will present a new post hoc analysis of Phase 2 data of the...
September 12, 2023
/PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive top-line data from the Phase 3 CAHtalyst™ Adult Study evaluating the...
June 8, 2023
On May 17, the U.S. Food & Drug Administration ("FDA") issued two important draft guidance documents, which clarify the agency's approach to requirements and incentives in the realm of pediatric drug development...
June 7, 2023
On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of...
June 7, 2023
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.