FDA re­jects Al­ny­lam’s On­pat­tro la­bel ex­pan­sion af­ter ad­comm vot­ed in fa­vor

The FDA has re­ject­ed Al­ny­lam Phar­ma­ceu­ti­cals’ ex­pan­sion plans for its siR­NA in­jec­tion On­pat­tro, serv­ing a com­plete re­sponse let­ter for the treat­ment of AT­TR car­diomy­opa­thy. …

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