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Shire wins CHMP backing for Adynovi

Haemophilia A treatment backed for European approval

- PMLiVE

Merck pulls Keytruda filing in Europe, despite US approval

Phase II KeyNote-0241 trial results failed to win over the EMA

- PMLiVE

Shire’s gene therapy candidate receives orphan drug status in the US

Investigational factor VIII treatment SHP654 is being developed for haemophilia

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Gilead wins European approval for triple hep C combination Vosevi

The treatment brings together sofosbuvir, velpatasvir and voxilaprevir

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Kite wins FDA approval for blood cancer drug Yescarta

Becomes the first CAR-T therapy approved in the US for B-cell lymphoma

Gilead Sciences promotes Dr Alessandro Riva to EVP, oncology therapeutics

He's been with the firm since January, when he joined from Novartis

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Ipsen’s liver cancer treatment clears phase III trial

Cabometyx on track for new liver cancer indication

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CHMP recommends Teva’s generic version of Astellas’ Advagraf

Committee backs the drug for transplant rejection prophylaxis

Roche Basel Switzerland

Roche wins CHMP nod for Alecensa licence extensions

Lung cancer monotherapy set for a broader European label

- PMLiVE

Moving times

Continuity and stability are vital when it comes to the EMA's relocation when it leaves London

- PMLiVE

EMA sets aside £32m for temporary staff to help with Brexit move

As agency warns current tender system needs to be updated

EU flag

Europe’s cancer drug regulation is ‘broken’, claims study

Suggests EMA oncology approvals could lead to wasted funds and patient harm

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