Bridget Silverman
Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
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 Offers Faster Route To Market Than EMA: Details On All 108 Approvals
Comprehensive table comparing all the novel agents approved by either the US FDA or the European Commission over 2023 through April 2024.