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Jenna Payesko

FDA

FDA Rejects Duchenne Muscular Dystrophy Drug Golodirsen, Citing Safety Concerns

August 23, 2019
  • Jenna Payesko

The regulatory agency cited 2 concerns in the complete response letter: the risk of infections related to intravenous infusion ports and renal toxicity.

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epilepsy

Diazepam Buccal Film Beneficial in Refractory Epilepsy With Seizure Clusters

August 12, 2019
  • Jenna Payesko

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.

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FDA Addresses Zolgensma Gene Therapy Data Manipulation

August 8, 2019
  • Jenna Payesko

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.

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