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Sarepta Therapeutics was “surprised” to receive a complete response letter from the FDA for its new drug application for Vydonos 53 (golodirsen) for treatment of Duchenne muscular dystrophy. Read More
Progressive groups organized a series of rallies across the country Tuesday as part of a “People Over Pharma Profits” day of action. The coalition — dubbed “Lower Drug Prices Now” — includes Public Citizen, Health Care for America Now, Families USA, and MoveOn. The group planned 51 “People Over Pharma Profits” events across 32 states. Read More
The FDA is planning a small pilot program to test how it handles nonclinical study data submitted electronically in SEND 3.1 format — a Clinical Data Interchange Standards Consortium (CDISC) standard the agency has moved towards to gather more study data. Read More