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In the News: October Regulatory and Development Updates

Camargo

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel

Delveinsight

Gannex Pharma has received Fast Track designation approval from FDA for its drug candidate ASC42 for non-alcoholic steatohepatitis (NASH). The FTA designation will help the pharma company to advance its research and development in the NASH landscape and help its commercialization in the market.