Drugs in the Pipeline
The Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the proposed labeling update of Rexulti (brexpiprazole; Otsuka and Lundbeck) for the maintenance treatment of adults with schizophrenia.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to tazemetostat (Epizyme) for the treatment of malignant rhabdoid tumors (MRTs).
The Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental New Drug Application (sNDA) of Kalydeco (ivacaftor; Vertex) in patients with cystic fibrosis (CF) ≥2 years old who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Amgen announced positive top-line data from the Phase 3 GAUSS-3 study evaluating Repatha (evolocumab) in statin-intolerant patients with high cholesterol.
The Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for MCNA (Telesta Therapeutics) in the treatment of non-muscle invasive bladder cancer (NMIBC).
TapImmune announced that the Food & Drug Administration (FDA) has granted Fast Track designation for its cancer vaccine TPIV 200 in the treatment of ovarian cancer.
The Food and Drug Administration (FDA) has granted Fast Track designation to NDI-010976 (Nimbus Therapeutics) for the treatment of non-alcoholic steatohepatitis (NASH)
Synergy Pharmaceuticals announced the submission of its first New Drug Application (NDA) to the Food and Drug Administration (FDA) for plecanatide for the treatment of chronic idiopathic constipation (CIC).
The Food and Drug Administration (FDA) has granted Fast Track designation to Ryanodex (dantrolene sodium; Eagle) injectable suspension for the treatment of exertional heat stroke (EHS).
Jazz Pharmaceuticals announced positive data from the Phase 3 pivotal study of defibrotide in patients with hepatic veno-occlusive disease (VOD) with multi-organ failure (MOF) post-hematopoietic stem-cell transplantation (HSCT). Findings were published online in Blood, the Journal of the American Society of Hematology (ASH).
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- FDA to Review Rexulti as Maintenance Therapy for Schizophrenia
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