Topic: New Drug Application
The 27-0 vote against approval followed questioning of Nektar’s decision to run one pivotal trial and the extent to which it assessed the abuse risk.
The FDA plans to increase the number of clinical offices and divisions and group them by therapeutic area.
The FDA rejected the New Drug Application for golodirsen, the follow-up to Exondys 51, Sarepta’s first treatment for Duchenne muscular dystrophy.
Vanda Pharmaceuticals received a Complete Response Letter from the FDA taking issue with a small study testing Hetlioz in jet lag disorder.
The trial suggests revefenacin has a tolerable safety profile comparable to that of Boehringer Ingelheim’s bronchodilator Spiriva.
GW Pharma's cannabis-based epilepsy treatment Epidiolex is firmly on track for a filing in the U.S. after new data published in the New England Journal of Medicine showed impressive effects on seizure rates.