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A complete response letter to Otsuka Pharmaceutical from the FDA shot down the company’s application for a drug/device combination product, saying the agency needs more data. Read More
The FDA is proposing to extend review times to enable more communication between the agency and sponsors to increase the number of first cycle approvals for biosimilars. Read More
Citing a national opioid crisis and the frequency of deaths associated with OxyContin overdoses, a lawmaker is asking FDA Commissioner Robert Califf about how the agency administers Risk Evaluation and Mitigation Strategies for prescription opioids. Read More
It’s been a tough road for Duchenne candidates this year, with one getting rejected outright and another facing an unsympathetic advisory committee panel next Monday. Read More