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- PMLiVE

Monkeypox

- 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

FDA slams Kardashian West’s Instagram drug promotion

Morning-sickness drug firm Duchesnay criticised over social media marketing

- PMLiVE

FDA grants priority review for new Keytruda licence

Merck’s PD-1 drug being assessed for first-line melanoma patients

- PMLiVE

FDA approves world’s first 3D printed drug

Aprecia’s epilepsy treatment Spritam seen as the future of drug manufacturing

- PMLiVE

US medicine regulation reforms passed by House

The 21st Centrury Cures Act could make sweeping changes if ratified

Eli Lilly HQ

Lilly closes on US approval of lung cancer drug necitumumab

Indication for NSCLC looking likely after informal panel poll

FDA teams up with PatientsLikeMe for patient data project

Will explore its potential to inform the regulator'approach to risk assessment

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