EMA Doubles Number Of EU Early Access Approval Recommendations
13 CHMP Positive Opinions Were For Conditional Marketing Authorization
The EU’s special provisions for speeding new products towards approval proved more popular than ever with drug sponsors last year.
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Stemline Therapeutics’ Elzonris was approved for a rare cancer in Europe in January, following a long and arduous two-year journey through the EU regulatory process that included an initial rejection and a subsequent re-examination by the EMA. Its fortunes were very different in the US, where the review took just six months from filing to approval.
Not everyone reviewing Daiichi Sankyo’s EU marketing application for Turalio agreed that the potential tenosynovial giant cell tumor treatment shouldn't be approved.
The European Medicine Agency has stood firm on its decision to recommend against pan-EU marketing approval for Gamifant.