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Astellas Pharma got an FDA green light last week when the agency accepted its New Drug Application (NDA) for fezolinetant — potentially the first-ever nonhormonal drug for hot flashes associated with menopause. Read More
The FDA has accepted Glaxo Smith Kline’s New Drug Application for momelotinib, just months after the behemoth snapped up the investigational myelofibrosis drug and the company that developed it — Sierra Oncology. Read More
The FDA has approved Bluebird Bio’s Zynteglo (betibeglogene autotemcel) for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. Read More