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- PMLiVE

LHON

- PMLiVE

EMA says adaptive pathways programme still needs refinement

Scheme aims to accelerate patient access to new drugs

- PMLiVE

EMA suspends generic drugs on data integrity concerns

Reports by FDA and WHO find evidence of data manipulation by Semler Research Centre

- PMLiVE

HIV prevention pill heads July CHMP recommendations

Gilead’s Truvada given positive opinion alongside Ipsen Pharma’s Cabometyx and Eisai’s Kisplyx

EU flag

EU proposes reforms to make first-in-human trials safer

New guideline revision paper “takes into account lessons learnt” from fatal Bial trial

- PMLiVE

Santhera facing long delay for muscular dystrophy drug in US

FDA rejects accelerated marketing application for Raxone to await phase II trial results

- PMLiVE

Gilead’s Zydelig passes EMA safety review

Risk of ‘serious infections’ outweighed by cancer drug’s benefits

- PMLiVE

EMA: ‘business as usual’ – for now – after Brexit

And says it will be up to remaining EU members to decide on its future location

- PMLiVE

Ypsomed’s touch screen insulin pump for Novo Nordisk approved by EMA

mylife YpsoPump given green light for use with pump cartridge NovoRapid PumpCart

Roche Basel Switzerland

Roche’s MS drug Ocrevus awarded priority review by FDA

Comes as Swiss company files the therapy with the FDA and EMA

- PMLiVE

Teva’s asthma treatment Cinqaero set for European approval

CHMP backs the antibody therapy for eosinophilic asthma

- PMLiVE

EMA recruits patient voices for its management board

Continues its drive to embed patients' values within drug assessment

Biomarin

BioMarin gives up on muscular dystrophy drug

Makes ‘difficult but necessary’ decision to abandon exon-skipping therapy Kyndrisa

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