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Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel

 
• By Sue Sutter

The 9 September meeting on Iterum Therapeutics' oral sulopenem product for uncomplicated urinary tract infections marks the first fully in-person advisory committee drug review since the COVID-19 pandemic hit in early 2020.

School bus
Like children returning to school, advisory committee members and public speakers will be returning to the FDA's White Oak headquarters in September. • Source: Shutterstock

The month of September will herald the first fully in-person US Food and Drug Administration advisory committee meeting on a new drug application since the start of the COVID-19 pandemic in 2020.

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EU Decision Time For Topical Gene Therapy Beremagene Geperpavec And Five Others

 
• By Eliza Slawther

The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.

GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 
• By Bridget Silverman

The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.

First Lassa Fever Vaccine Wins EMA PRIME Designation; Advanced Therapies Dominate 2024 Entries

 
• By Neena Brizmohun

Two investigational products have made it onto the European Medicines Agency’s priority medicines scheme so far this year. Meanwhile, of the 14 products that entered the scheme last year, six were advanced therapies.