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Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU
Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.
Cancer, Gene Therapy Top US FDA’s Second Half 2024 User Fee Calendar
Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.
US FDA Calls ’Em Like Its Advisory Committees See Them
So far this year, when the agency has taken action on NMEs that went before advisory committees, the FDA decision has matched the committee vote.
Coming Attractions: Novel Agents In Line For US FDA Decisions By Year-End
Interactive table from the Pink Sheet breaks down the 40 novel drugs and biologics have user fee goal dates before the new year.
Steady On For US FDA’s Novel Approvals At Mid-Year, But Another 2023 Is Unlikely
US FDA would need to approve 44 novel agents by year-end to match 2023’s big total, but only 40 candidates are known to have user fee goals in the second half of 2024.
Rare Diseases Rule, But Some Common Conditions Stand Out In Pending US Applications
Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.
US FDA’s Dry July? Few Goal Dates Portend Quiet Month For Approvals
Sun’s deuruxolitinib and Novo Nordisk’s insulin icodec stand out as new molecular entities among the small cluster of US FDA user fee goal dates in July.
US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer
June goal dates include RSV and pneumococcal vaccines, two COPD therapies, Rocket and Sarepta gene therapies, and lots of oncology.
US FDA’s Novel Approvals Peak Near Year-End, Analysis Of Last Decade Suggests
The Center for Drug Evaluation and Research’s novel approvals concentrated in August, November, and December, while January and June were the slowest months, according to a Pink Sheet analysis of 2014-2023 data.
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