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- PMLiVE

Horizon Pharma

- PMLiVE

Flurry of FDA guidance firms up biosimilar policy

The American regulator has released new biosimilar Q&A document

- PMLiVE

Merck KGaA, Threshold gain FDA fast-track review

Industry partners hope their new cancer drug will be approved by the end of the year

- PMLiVE

Amarin sues FDA over off-label policy

Claims block on discussing off-label uses conflicts freedom of speech

- PMLiVE

Kythera bags FDA approval for double chin therapy

Comes as cosmetics industry sees major growth

- PMLiVE

Takeda to pay $2.4bn to settle Actos cancer suits

Will be one of the largest drug safety settlements in US history

Sanofi reception

Sanofi gains accelerated review for rare disease drug

New pill for Fabry disease could be approved by the FDA before the end of the year

- PMLiVE

Merck files Keytruda for lung cancer

Filed to the FDA as a treatment option for NSCLC patients

- PMLiVE

AZ and Takeda drugs should carry heart failure warning

FDA panel claim diabetes drugs Onglyza and Nesina need label updates

- PMLiVE

ReNeuron aiming to take second stem cell therapy into clinic

Will test its human retinal progenitor cell for genetic eye disease RP

- PMLiVE

FDA reviewer backs approval of TMC’s cangrelor

Claims it offers a small benefit over Sanofi’s Plavix

- PMLiVE

AZ’s Onglyza may increase mortality, says FDA

Kombiglyze also under scrutiny

- PMLiVE

US cancer drug prices ‘not rational’

New research from the medical journal JAMA adds to growing pressure over pricing

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