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Maureen Kenny
Executive Editor
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Latest From Maureen Kenny
Decision Time For MSD/AZ, Lilly, Kite EU Fast-Track Hopes
Three accelerated assessment requests will either be granted or rejected this week at the European Medicines Agency.
EMA Prepares Approval Verdict On Beovu, Idhifa, Recarbrio
Products from Novartis, Celgene and Merck could get an EU approval recommendation at this week's CHMP meeting.
Orchard’s Gene Therapy Under Fast-Track Review At EMA
Daiichi Sankyo Plays Long Game With Quizartinib Outside Japan
Japanese company Daiichi Sankyo has its eye on first-line FLT3-ITD AML indication after rejection of relapsed/refractory plans in EU and US.
EU: Rigel And Jazz Among Hopefuls At CHMP
Rigel Pharmaceuticals and Jazz Pharmaceuticals are among the companies that could find out this week whether their new drug applications at the European Medicines Agency are likely to be approved for marketing across the EU. The EMA's key scientific committee, the CHMP, will also consider applications from Roche and Novartis.
EU: Stakes High For Novartis At Latest CHMP Meeting
Novartis is likely to hear this week whether siponomid and osilodrostat will be recommended for marketing across the EU.