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Keppra

- PMLiVE

FDA approves Sanofi’s four-in-one flu vaccine

But wants more safety data for hepatitis B vaccine from Dynavax

- PMLiVE

FDA turns down tivozanib for kidney cancer

Agency describes data provided by Aveo Oncology and Astellas as "uninterpretable"

- PMLiVE

FDA panel says Avandia restrictions should be eased

Vote backs wider use of GSK's drug in diabetes

- PMLiVE

FDA to review restrictions on GSK’s diabetes drug Avandia

Advisory committee to discuss re-analysis of diabetes drug’s safety data

- PMLiVE

Regulatory struggles force Aveo to cut 140 jobs

Expects FDA rejection for tivozanib in kidney cancer

- PMLiVE

FDA gives priority review status to BMS/ AZ’s metreleptin

Former obesity prospect has potential in the rare disease lipodystrophy

- PMLiVE

GSK/ Valeant’s Trobalt set for EU restrictions

Eye concerns prompt CHMP to recommend last-line use for the epilepsy drug

- PMLiVE

FDA clears two GSK melanoma drugs

Tafinlar and Mekinist approved in the US along with companion diagnostic

- PMLiVE

FDA gives Alexion’s metabolic drug breakthrough status

Reduces requirements for registration, potentially speeding up approval

- PMLiVE

US FDA approves Roche’s assay as first blood test to diagnose diabetes

Will help catch diabetes early in country where seven million people are undiagnosed

- PMLiVE

Merck & Co inches closer to US green light for insomnia drug

FDA panel backs suvorexant, although some concerns about high dosages

UCB and IBM to harness big data for personalised epilepsy care

Joint project could pave the way for therapy area use of IBM's Watson

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