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EU nod for Bayer’s Stivarga as Nexavar gets US priority review

Advances pharma company’s ambitions in cancer

- PMLiVE

Novartis orphan drug wins ‘breakthrough’ status from FDA

Bimagrumab could be first treatment for rare life-threatening muscle-wasting condition

EMA prepares for digital signature introduction

From next month will accept digital signatures for certain procedures

- PMLiVE

ViiV gets US nod for HIV drug dolutegravir

GSK and Pfizer joint venture on course for first drug launch

- PMLiVE

Malaria vaccine gives “unprecedented” results

Able to protect 12 out of 15 people in phase I trial

- PMLiVE

GSK submits Votrient for ovarian cancer in Europe

Pharma company hopes for extra indication for oncology product

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Bayer moves closer to US approval of PAH drug riociguat

FDA panel votes unanimously in favour of hypertension treatment

- PMLiVE

FDA panel turns down Otsuka’s drug for rare kidney disease

Unable to recommend expanded use of tolvaptan

- PMLiVE

GSK’s diabetes hope albiglutide delayed in US

FDA extends deadline to April 2014

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EC sets up expert group on rare diseases

Will revamp EUCERD to better handle development of orphan medicines

Sanofi reception

FDA panel backs OTC use of Sanofi’s allergy drug

Says Nasacort AQ can be sold without prescription

- PMLiVE

EMA’s head of human medicines development steps down

Patrick Le Courtois leaves regulator after 16 years

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