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- PMLiVE

Janet Woodcock

- PMLiVE

FDA approves Pfizer’s new cancer pill

Drug was previously approved as an organ rejection treatment

- PMLiVE

Sanofi pays $245m for FDA priority review voucher

PRV reduces review time from ten to six months

- PMLiVE

FDA approves two new IBS medicines

US regulator gives the nod to Actavis’ and Salix’ bowel drugs

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Amgen’s immuno-oncology drug scores in skin cancer

Firm hoping its novel treatment will be on the market be the end of this year

- PMLiVE

US lawmakers pass new bill to speed up drug reviews

FDA will also need to take the views of patients into greater consideration under new plans

- PMLiVE

FDA warns of safety concern with SGLT2 inhibitors

Some drugs have been linked to high levels of blood acids

- 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

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