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The FDA has approved a new drug co-developed by Valeant Pharmaceuticals and Progenics Pharmaceuticals that treats opioid-induced constipation in adults. Read More
Sandoz’s application to produce a biosimilar of Amgen’s bone marrow drug Neulasta has been rebuffed by the agency, according to Sandoz’s parent company, Novartis. Read More
When given the opportunity to use real-world data and adaptive trial designs to secure marketing authorization, drug sponsors often struggle to develop innovative approaches. Read More
When given the opportunity to use real-world data for drug approvals, sponsors scramble to conceive innovative approaches, an EMA official said. Read More
The Office of Generic Drugs has taken action on more than 90 percent of its backlog of ANDAs and prior approval supplements, more than 15 months ahead of schedule, CDER Director Janet Woodcock announced Monday. Read More