The FDA has granted fast track designation for abenacianine to help surgeons better visualize lung tumors during minimally ...
LYT-200 now has gained fast track designation from the FDA in acute myeloid leukemia in addition to its prior designation for ...
The FDA has granted fast-track designation to an investigational small molecule to treat individuals with Fragile X syndrome, ...
BBO-8520, an investigational oral agent, has been granted fast track designation from the FDA in previously treated KRAS G12C ...
The FDA has granted Fast Track designation to SPG601 for the treatment of Fragile X syndrome, a common inherited cause of autism.
"I am thrilled that the FDA has granted Fast Track designation to SPG601 for FXS, highlighting its potential as a novel therapeutic option for a disease that, to this day, has no approved ...
Shares of biotech Summit Therapeutics ( SMMT 9.31%) skyrocketed 583.7% in 2024, according to data from S&P Global Market ...
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
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