Healio3d
FDA grants fast-track designation to small molecule for Fragile X
The FDA has granted fast-track designation to an investigational small molecule to treat individuals with Fragile X syndrome, ...
Becker's Hospital Review2d
Watchdog flags flaws in FDA's fast-track drug approvals
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 ...
Targeted Oncology3d
LYT-200 Gains FDA Fast Track Status in Acute Myeloid Leukemia
LYT-200 now has gained fast track designation from the FDA in acute myeloid leukemia in addition to its prior designation for ...
Cure Today6d
FDA Grants Fast Track Designation for Abenacianine in Lung Cancer Surgery
The FDA has granted fast track designation for abenacianine to help surgeons better visualize lung tumors during minimally ...
Neurology Advisor14h
Novel BK Channel Activator Fast Tracked for Fragile X Syndrome
The FDA has granted Fast Track designation to SPG601 for the treatment of Fragile X syndrome, a common inherited cause of autism.
Yahoo Finance4d
FDA Grants Fast Track Designation to Spinogenix's SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form 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 ...
Targeted Oncology4d
FDA Grants BBO-8520 Fast Track Status in KRAS G12C-Mutant NSCLC
BBO-8520, an investigational oral agent, has been granted fast track designation from the FDA in previously treated KRAS G12C ...
Pharm Exec11d
FDA Grants Fast Track Designation to Vergent Bioscience’s Novel Agent for Visualizing Solid Tumors During Lung Cancer Surgeries
Fast Track designation was based on results from a Phase II study, which demonstrated that VGT-309 was safe, well-tolerated, and enhanced tumor visualization in lung cancer patients. The FDA has ...
PureTech announces receipt of FDA Fast Track Designation for LYT-200 in AML
PureTech Health (PRTC) announced that the U.S. Food and Drug Administration has granted Fast Track designation to LYT-200, a ...
Nasdaq7d
Mersana Therapeutics Receives Additional FDA Fast Track Designation for XMT-1660 in Advanced Breast Cancer Treatment
Mersana Therapeutics, Inc. announced that the FDA has granted an additional Fast Track designation for its drug XMT-1660, also known as emiltatug ledadotin (Emi-Le), aimed at treating advanced or ...