CHMP issues negative opinion for renewal of conditional marketing authorisation for Translarna (ataluren) following re-examination procedure

PTC Therapeutics

25 January 2024 - PTC Therapeutics announced today that the CHMP of the EMA issued a negative opinion following the re-examination procedure for the conditional marketing authorisation of Translarna (ataluren).

Per European regulations, the European Commission has 67 days to adopt the opinion.

Read PTC Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Regulation