Biomarker Is King In Latest US FDA Cancer Drug Approval
Accelerated approval for patients with microsatellite instability-high or mismatch repair deficient solid tumors is the first time the US regulatory agency has granted an indication that does not specify the location of the tumor – a change that precision-medicine researchers have been eager to make.
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The promise of next-generation sequencing technology to help patients understand risk and target treatment for disease is high. US FDA is hoping to help accelerate practical advancements with the release of two final guidances addressing NGS technology and databases that aggregate genomic information.
Keeping Track: Teva's Austedo Clears US FDA, Merck Sitagliptin CV Outcomes Labeling Draws Complete Response
The latest drug development news and highlights from our FDA Performance Tracker.
Pioneering enrollment strategies are coupled with adaptive statistical designs in the next wave of basket trials from NCI, ASCO and Novartis.