Charleston Laboratories, Inc.

A second advisory committee meeting to consider additional information about Amylyx Pharmaceuticals, Inc. ’s amyotrophic lateral sclerosis (ALS) drug AMX0035 may be an attempt by the US Food and Drug

The process for eliminating a Risk Evaluation and Mitigation Strategy could become more transparent thanks to the prescription drug user fee reauthorization. Among the final details the PDUFA VII Post

There is very little reference to the US Food & Drug Administration in the settlement documents released by the Department of Justice in its resolution of opioid litigation with Purdue Pharma L.P. T

US Food and Drug Administration advisors’ general lack of confidence in risk evaluation and mitigation strategies ability to lessen safety concerns with drugs appeared to be a significant factor in th