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.
You may also be interested in...
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.
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.
Axsome Therapeutics’ lead candidate, AXS-05, was nearing the US market for major depressive disorder, but the US company is trying to find out more about deficiencies identified by US regulators; the biotech has also reported positive Phase II results in treatment-resistant depression.