FDA Rejects Duchenne Muscular Dystrophy Drug Golodirsen, Citing Safety Concerns
August 23, 2019
The regulatory agency cited 2 concerns in the complete response letter: the risk of infections related to intravenous infusion ports and renal toxicity.
Jenna Payesko
Diazepam Buccal Film Beneficial in Refractory Epilepsy With Seizure Clusters
August 12, 2019
The new drug application for Libervant is expected to be completed in the fourth quarter of 2019, which if approved, would offer a potentially first in class oral treatment for breakthrough or cluster seizures.
FDA Addresses Zolgensma Gene Therapy Data Manipulation
August 8, 2019
The agency said the gene therapy should remain on the market while it assesses the situation and does not impact their evaluation of data from the human clinical trials.
