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The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended AveXis’ spinal muscular atrophy gene therapy Zolgensma along with seven other medicines at its March meeting. Read More
The drug is currently indicated in combination with ribavirin to treat pediatric patients six years and older or weighing at least 37 pounds with severe cirrhosis. Read More
In a surprise move based on public outcry, Gilead asked the FDA to rescind remdesivir’s orphan drug designation as a potential COVID-19 treatment. Read More
Eli Lilly and Boehringer Ingelheim received a complete response letter from the FDA for their supplemental NDA for Jardiance (empagliflozin) 2.5mg as an adjunct to insulin for adults with type 1 diabetes. Read More
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