The Food and Drug Administration (FDA) has granted Fast Track designation to 4P004, an intra-articularly administered glucagon-like peptide-1 receptor agonist (GLP-1RA), for the treatment of knee ...
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 priority review vouchers to three psychedelic-based therapies—two psilocybin programs for depression and ...
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 ...
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 ...
FDA fast tracked ZW191 for platinum-resistant ovarian cancer, aiming to speed development of a potential new option for patients with limited treatments. The U.S. Food and Drug Administration (FDA) ...
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 ...
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 ...
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