Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...

The FDA has granted Fast Track designation to SPG601 for the treatment of Fragile X syndrome, a common inherited cause of autism.

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 ...

Shares of biotech Summit Therapeutics ( SMMT 9.31%) skyrocketed 583.7% in 2024, according to data from S&P Global Market ...

The FDA has granted fast-track designation to an investigational small molecule to treat individuals with Fragile X syndrome, ...

LYT-200 now has gained fast track designation from the FDA in acute myeloid leukemia in addition to its prior designation for ...

Dr. Chen is developing a new delivery system which is designed to help cancer drugs cross the blood-brain barrier.

BBO-8520, an investigational oral agent, has been granted fast track designation from the FDA in previously treated KRAS G12C ...

Mersana Therapeutics, Inc. recently disclosed encouraging updates in a Form 8-K report filed with the Securities and Exchange Commission. The company unveiled positive initial clinical data from the ...

The FDA has granted fast track designation for abenacianine to help surgeons better visualize lung tumors during minimally ...

Mersana shares Phase 1 data on Emi-Le for TNBC and details FDA's Fast Track status for XMT-1660 in advanced HER2-low breast ...