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The average cost of developing a new drug continues to rise, even as approval success rates continue to fall, according to a report that pegs the cost of ushering a candidate through FDA approval at an eye-popping $2.6 billion. Read More
Makers of protein-based biologics approved under the NDA pathway will lose all exclusivity rights in four years, and any NDA or ANDA that hasn’t been approved by March 23, 2020, will be voided. Read More
The European Medicines Agency has launched an investigation into Gilead Sciences’ cancer drug Zydelig following an increase in serious adverse events. Read More