U.S. FDA Fast Track Designation for vididencel in Acute Myeloid Leukemia (AML)
“As part of the preparations for continued clinical development of vididencel in AML, we continue to strengthen the program in all product-relevant aspects, including on the regulatory front,” commented Jeroen Rovers, MD PhD, Chief Medical Officer of Mendus. “The Fast Track Designation granted by the FDA adds substantial regulatory value to the vididencel program in the most important healthcare market worldwide. As Mendus advances vididencel into the next phase of clinical development in AML maintenance, the Fast Track Designation will allow the Company to engage more frequently with the FDA to optimally align its development plan.”
Share:
More News
“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across
“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed
“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three
“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000