Enolen's fast track designation by the FDA aims to expedite its development for localized prostate cancer treatment, addressing unmet medical needs. The localized delivery technology targets ...
The FDA has granted Regenerative Medicine Advanced Therapy designation to NouvNeu001, a cell therapy for Parkinson’s disease. NouvNeu001, developed by iRegene, is the first allogeneic cell therapy ...
A phase 2 trial evaluating CS-1103 in participants with methamphetamine use disorder is expected to begin in the first quarter of 2026. The Food and Drug Administration (FDA) has granted Fast Track ...
HDP-101, an ADC, received FDA fast track designation for multiple myeloma, highlighting its potential in addressing unmet medical needs. Phase 1/2a trials show HDP-101's promising efficacy and ...
ABBV-CLS-628 is currently being evaluated in a phase 2 trial in an estimated 240 adults with ADPKD class 1C, 1D, or 1E. The Food and Drug Administration (FDA) has granted Fast Track designation to ...
The FDA's Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions. The Food and Drug Administration (FDA) has granted Fast Track ...
Novartis received breakthrough therapy designation from the FDA for ianalumab, a monoclonal antibody aimed at treating Sjögren’s disease. Ianalumab works by depleting B cells and blocking BAFF-R ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results