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- PMLiVE

eosinophilic

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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

EMA backs Pomalidomide Celgene in multiple myeloma

Further positive CHMP opinions for new medicines form Aegerion, Teva and more

- 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

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

FDA panel backs suvorexant, although some concerns about high dosages

- PMLiVE

France ignores EMA and suspends Bayer’s Diane 35

National Agency for the Safety of Drugs and Health Products contradicts PRAC verdict

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EMA says Bayer’s Diane 35 should remain on European market

Agency investigation concludes acne treatment's benefits outweigh its risks

- PMLiVE

J&J’s Simponi wins FDA approval in ulcerative colitis

Adds to rheumatoid arthritis, psoriatic arthritis and active ankylosing spondylitis indications in the US

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