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- PMLiVE

pramipexole

Sanofi reception

Sanofi’s lixisenatide is back under FDA review

Brings GLP-1 agonist closer to US market

- PMLiVE

FDA clears Taiho’s oral colorectal cancer drug

Regulatory nod for Lonsurf gives patients additional treatment options

- PMLiVE

Amgen granted priority review for extended use of Kyprolis

Trial data shows myeloma drug's improvement over Velcade

- PMLiVE

Obama to nominate Dr Robert Califf as FDA commissioner

Thecardiologist is the frontrunner to replace Margaret Hamburg

- PMLiVE

J&J’s Invokana receives new FDA safety warning

Additional trial data highlights bone problems

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AbbVie’s Humira wins ninth US approval

FDA approves multi-blockbuster for inflammatory skin disease

Biosimilars – the same, but different?

As more products reach European markets, US regulations are catching up with science

- PMLiVE

FDA follows WHO lead on biosimilar naming

Proposes adding suffixes to distinguish biosimilar drug names

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FDA clears Jardiance combo for type 2 diabetes

Combination treatment Synjardy is fifth drug to come from Boehringer/Lilly diabetes alliance

Eli Lilly HQ

Lilly and Boehringer launch Lantus biosimilar in UK

Competition in the insulin drug market begins to heat up

- PMLiVE

FDA grants Tocagen’s glioblastoma drug orphan status

Puts the brain cancer gene therapy in-line for development incentives

- PMLiVE

Jardiance is first diabetes drug to improve CV outcomes

Lilly/Boehringer drug could gain market share boost from new data

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