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
Lamine Mbow, Global Head of Discovery Research, Boehringer Ingelheim, said: “We are building a broad pipeline of ADCs addressing novel tumor target space to develop next-generation cancer treatments. By combining our deep expertise in cancer treatment development with Synaffix’s clinical-stage platform technology, we aim to accelerate the delivery of first-in-class
“The initial therapy of high-risk, non-muscle invasive bladder cancer with BCG has not advanced in decades. Today’s pivotal Phase 3 CREST results are potentially practice-changing, representing the first advance in therapy for BCG-naïve, high-risk, non-muscle invasive cancer in over 30 years,” said Roger Dansey, M.D., Chief Oncology Officer, Pfizer. “These
“Receiving FDA IND clearance is an important milestone in the advancement of TYRA-300 and for patients with NMIBC who urgently need better tolerated therapeutic options,” commented Doug Warner, Chief Medical Officer of TYRA. “We look forward to leveraging Erik’s impressive background to guide our development plans in NMIBC. We expect
“As a leader in hematologic malignancies, AbbVie is committed to advancing innovative treatments for complex cancers like multiple myeloma through our relentless R&D efforts and collaborations,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “We look forward to partnering with Simcere Zaiming, to advance
