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Pfizer Claims Fourth Breakthrough Product Designation, But Joins Others in Citing Unclear Benefit

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Pharmaceutical manufacturing giant Pfizer has announced that its breast cancer candidate palbociclib has received a new and coveted breakthrough product designation from the US Food and Drug Read More...

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J&J Obtains Breakthrough Product Designation for Ibrutinib, But as With Vertex, Value Unclear

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The US Food and Drug Administration (FDA) has granted its third breakthrough product designation and the first for an entirely unapproved product, the product's sponsor, Jenssen, announced Read More...

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Vertex

Former FDA Commissioner: 'New Paradigm Shift' Means Agency Must Approve Treatments Faster

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Former US Food and Drug Administration (FDA) Commissioner Mark McClellan, now a member of the think tank The Brookings Institute, penned an opinion piece in The Hill in which he argues FDA must take Read More...

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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

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Pfizer Claims Fourth Breakthrough Product Designation, But Joins Others in Citing Unclear Benefit

J&J Obtains Breakthrough Product Designation for Ibrutinib, But as With Vertex, Value Unclear

Former FDA Commissioner: 'New Paradigm Shift' Means Agency Must Approve Treatments Faster

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