The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to a cancer drug called dostarlimab ...
On December 20, 2024, the FDA granted accelerated approval to the combination of encorafenib (Braftovi), cetuximab (Erbitux), ...
The FDA has granted breakthrough therapy designation Trodelvy for adults with extensive-stage small cell lung cancer who ...
What new medicines are poised to take the leap from breakthrough to approval in 2025? Here’s what to expect this year.
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The FDA recently approved the treatment by Novo Nordisk for hemophilia A or B with inhibitors, designed to prevent or reduce ...
Precigen submits BLA for PRGN-2012 gene therapy targeting RRP, a rare and life-threatening condition with no cure.
Only a few patients have undergone an intensive gene therapy cure for sickle cell disease since it was approved by the FDA ...
Nuvation Bio (NUVB) said the FDA has accepted its application with priority review for taletrectinib in the treatment of advanced ROS1+ non-small cell lung cancer. Read more here.
The US FDA has approved olezarsen (Tryngolza) as the first treatment for adults with familial chylomicronemia syndrome, a ...