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No decision from EU drug regulator yet on Wegovy label expansion

LONDON (Reuters) -The EU's drug regulator said on Friday it would continue to review whether Novo Nordisk's popular weight-loss drug Wegovy could also be used in some cases to reduce the risk of strokes and heart attacks. The expert panel assessing Novo's request to include certain heart benefits in the product's label did not adopt an opinion, a spokesperson for the regulator said. "The application is still under review and we cannot speculate on when it will conclude...
City Of United Kingdom Jason Neely Josephine Mason Elaine Hardcastle Committee For Medicinal Products Human Use
Source: yahoo.com

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PTC Therapeutics - CHMP Issues Negative Opinion for Renewal of Conditional Marketing Authorization for Translarna Following Re-examination Procedure

SOUTH PLAINFIELD - PTC Therapeutics, Inc. announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative opinion following the...
United States Kylie Okeefe Matthewb Klein European Medicines Agency Committee For Medicinal Products Human Use Therapeutics Inc

Apellis: EU's CHMP Adopts Negative Opinion For Pegcetacoplan For GA; To Seek Re-Examination Of MAA

Apellis Pharmaceuticals, Inc. (APLS) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a negative opinion for Pegcetacoplan for geographic atrophy or GA.
Jeffrey Eisele More Such Health News Apellis Pharmaceuticals Inc Apellis Pharmaceuticals European Medicines Agency Medicinal Products

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