Missed Review Deadlines Are Reminder That On-Time Approvals Are A Goal, Not A Guarantee
After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.
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Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half
With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.
Takeda's Livtencity Approved For Refractory CMV Infection In Transplant Patients
Maribavir is the first antiviral agent targeting and inhibiting the pUL97 protein kinase, as well as Takeda's second new molecular entity approved by FDA this year.
Sanofi/Regeneron’s Esophagitis Data Add To Dupixent’s Winning Streak
The companies announced positive Phase III data for the drug in patients with eosinophilic esophagitis and plan to take the results to regulators in 2022.