FDA rebuff deals big blow to Novo Nordisk’s U. S. hopes
COPENHAGEN (Reuters) – U. S. regulators dealt a major blow to Novo Nordisk’s hopes for its new long-acting insulin Tresiba by demanding the Danish drugmaker conduct additional clinical tests to assess potential heart risks. Novo, the world’s biggest insulin maker, said the U. S. Food and Drug Administration (FDA) had requested additional data from a dedicated cardiovascular outcomes trial before it would consider approving Tresiba and related product Ryzodeg. . . .
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