Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. The ... Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self ...