Keeping Track: FDA Delays Elagolix, Mylan Eyes For Neulasta Biosimilar Approval, And Duvelisib Gets Priority Review

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

Here's your US review and approval news in brief: AbbVie Inc. and Neurocrine Biosciences Inc.

will have to wait until the third quarter for a decision on their endometriosis-associated pain treatment elagolix, as FDA pushed...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

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Regeneron’s Linvoseltamab CRL Underlines Risks Of Third-Party Manufacturers

 

The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.

Facility Deficiencies Drive Rising CRL Rates For CDER Biologics

 

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

EU Biosimilar Filings, Opinions And Approvals

 
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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.

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Facility Deficiencies Drive Rising CRL Rates For CDER Biologics

 

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

Novartis Takes Fight To The FDA After US Entresto Generic Approval

 
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Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.

EU Biosimilar Filings, Opinions And Approvals

 
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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.