On August 6, 2019, the FDA issued a statement on data manipulation/inaccuracy issues with Zolgensma, a virus vector-based gene therapy approved for one-time IV treatment of children <2 years old with spinal muscular atrophy.1 We reviewed Zolgensma in our July 29 issue.2 According to the FDA statement, the manipulated data pertained to the production process for the product and did not affect the efficacy or safety results from the human clinical trials. It does not require any change in our review.

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More from Issue 1579
Previous Issue: 1578      August 12, 2019
Coming Soon
Drugs for Atrial Fibrillation
Ezallor Sprinkle - A New Formulation of Rosuvastatin
Nasal Glucagon (Baqsimi) for Hypoglycemia
Influenza Vaccine for 2019-2020
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Advance Release
The FDA has approved Qmiiz ODT (TerSera), an orally disintegrating tablet formulation of the prescription NSAID meloxicam. Qmiiz ODT, like conventional oral meloxicam tablets (Mobic, and generics), is indicated for relief of the symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) in adults and of juvenile RA in children who weigh ≥60 kg. Vivlodex, a low-dose capsule formulation of meloxicam, is FDA-approved only for management of OA pain. ... Continue reading