Dozen Novel Agents Dream Of August US FDA Approval

A stacked user fee goal lineup sets the stage for market showdowns in primary biliary cholangitis and IgA nephropathy, the first psychedelic approval decision, and lots of targeted cancer therapies.

heating up
After a slow July, the FDA's review goal calendar is heating up. • Source: Shutterstock

Summer may wind down in August, but the US Food and Drug Administration will be revving up for a spike in user fee goal dates that includes 12 novel candidates, the Pink Sheet US FDA Performance Tracker shows.

More from US FDA Performance Tracker

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

US FDA’s March Approval Candidates Take Aim At Established Markets

 

March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.

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

 

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.

Rapidly Rising RMAT Designations Crack CBER’s Communication Freeze

 

The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.

More from Regulatory Trackers