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Drug Approvals

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Latest From Approvals

US FDA’s End-Of Year Approval ‘Rush’ And Other Criticisms: Fact Or Fiction?

FDA has been criticized in recent months for approving drugs too quickly, based on insufficient evidence. The agency’s oncology chief Richard Pazdur fights back.

Cancer Drug Approval Standards

Richard Pazdur: 20th Anniversary Edition

US FDA oncology chief celebrates his 20th year at the agency with a frank and wide-ranging podcast interview in which he addresses the next (two) phases of the Oncology Center of Excellence, his ‘think it/do it’ mentality, and whether advisory committees still give good advice.

Cancer FDA

EU 2019 Approvals: Novel Therapies Make Strong Showing

Bluebird bio’s gene therapy Zynteglo, Akcea’s antisense drug Waylivra and BioMarin’s enzyme substitution therapy Palynziq were among the novel innovative medicines that were approved in Europe in 2019. 

Europe Approvals

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Europe European Performance Tracker

Keeping Track: Ayvakit Approval, Keytruda Supplement, NME Submissions

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Pink Sheet Podcast: The Most Impactful Stories Of 2019

Pink Sheet reporters review the major issues that emerged during the past year and how they will impact 2020.
FDA Leadership
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