Genentech Submits Additional Lucentis Data To FDA

Label for Lucentis, pending for wet age-related macular degeneration, could include data from a Phase IIIb study supporting continuous treatment.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Publisher’s Spotlight: Shortlist Unveiled For Citeline Japan Awards

 
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Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!

Ex-CDC Leaders Reveal New Details Of Kennedy’s Plans For ACIP, Vaccine Schedule

 

The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.

More NME Reviews, Reduced Costs Combine To Lower US FDA Voucher Fee

 

The FDA said new molecular entity application reviews increased and cost less in fiscal year 2024, a potentially encouraging sign for industry.