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- PMLiVE

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- PMLiVE

FDA clears Amgen’s Xgeva for rare bone condition

US approval provides alternative to surgery for use in giant cell tumour of the bone

- 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

Celgene’s Revlimid wins US lymphoma approval

FDA recommends extra indication for blockbuster cancer drug

- 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

FDA clears two GSK melanoma drugs

Tafinlar and Mekinist approved in the US along with companion diagnostic

- PMLiVE

Orphan status in US for Astellas/ Basilea antifungal

Isavuconazole is being developed as a treatment for invasive aspergillosis

- 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

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