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FDA Breakthrough Therapy Designation Granted For Promising Rectal Cancer DrugThe US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to a cancer drug called dostarlimab ...
The FDA has granted breakthrough therapy designation Trodelvy for adults with extensive-stage small cell lung cancer who ...
Hugely promising cancer drug dostarlimab is one step closer to being widely available, after the Food and Drug Administration ...
Shares of Precigen PGEN have soared nearly 43% in the past week after the company provided an encouraging regulatory update ...
Jemperli received breakthrough therapy designation by the FDA for locally advanced mismatch repair deficient/microsatellite ...
Sumitomo Pharma's Gemtesa (vibegron) has been approved by the U.S. Food and Drug Administration for men with overactive ...
What new medicines are poised to take the leap from breakthrough to approval in 2025? Here’s what to expect this year.
Sanofi SNY announced that the FDA has granted a Breakthrough Therapy designation to its investigational oral BTK inhibitor, tolebrutinib, for treating adults with non-relapsing secondary ...
Precigen submits BLA for PRGN-2012 gene therapy targeting RRP, a rare and life-threatening condition with no cure.
The FDA recently approved the treatment by Novo Nordisk for hemophilia A or B with inhibitors, designed to prevent or reduce ...
The analyst remains optimistic about AXS-05's approval, highlighting that the FDA's continued designation of AXS-05 as a ...
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