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- PMLiVE

major thrombotic cardiovascular events

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

Merck prepares filings for Clostridium antibody

Moves bezlotoxumab closer into position for regulatory approval

- 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

- PMLiVE

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

- PMLiVE

FDA grants Tocagen’s glioblastoma drug orphan status

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

- PMLiVE

Intarcia’s diabetes implant beats Merck’s Januvia in trial

New injection-less therapy could revolutionise diabetes treatment

- PMLiVE

FDA slams Kardashian West’s Instagram drug promotion

Morning-sickness drug firm Duchesnay criticised over social media marketing

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