April 22nd 2024
Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
April 11th 2024
Otsuka, Lundbeck Submit sNDA for Rexulti in Adolescents with Schizophrenia
October 15th 2021Submission is based on extrapolation analysis and results examining the effects of Rexulti in treating symptoms of schizophrenia in patients 13 to 17 years old. The FDA is expected to complete its review in December 2021.
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