FDA Performance Tracker
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BeiGene’s Tevimbra And The End Of The COVID Inspection Era
US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.
Novo Nordisk’s Semaglutide Achieves ‘Cardiodiabesity’ Label
With Wegovy’s new indication for cardiovascular risk reduction in patients with overweight and obesity, the migration of diabetes drugs from a single disease state to address a host of interrelated conditions reaches a new milestone.
Late-in-Review Advisory Panels: What Previous Cases Tell Us About Donanemab’s Prospects
Lilly’s Alzheimer’s candidate joins a club that no sponsor wants to be in, but one in which some members do get approved, albeit with less-than-ideal labeling.
Marching On: Eight Novel Agents Among March Goal Dates For US FDA
Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.
Breakthrough Designation Binge In February By US FDA Didn’t Extend To Approvals
Six new breakthrough therapy designations have been announced, all for novel agents, but approvals were fewer and limited to new indications and formulations.
A Visual Trip Through The Psychedelic Pipeline
Pink Sheet infographic breaks down the status of origins of 39 programs being pursued by 26 sponsors.
Keeping Track: Iovance’s Amtagvi Approval Brings T Cell Therapy To Solid Tumors
Melanoma treatment Amtagvi is US FDA’s biologics center’s first novel approval of 2024.
FDA’s Dry January: Little Novel Application Activity, But That Doesn’t Mean No Fun
US FDA’s drugs center posted one of its lowest monthly approval counts of original applications in January, but new indications filled the gap, including new claims for Merck’s Keytruda, Takeda immunoglobulins, and Sanofi/Regeneron’s Dupixent.
As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023
Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
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