FDA issues CRL for Dasynoc™ (dasatinib) NDA for the treatment of CML and ALL
“It is unfortunate that manufacturing-related issues beyond our control are delaying our launch. We have made significant progress in the regulatory review and maintained discussions with the FDA regarding the product information for Dasynoc up to the PDUFA date,” said Per Andersson, CEO of Xspray Pharma. “We will now work closely with both the manufacturer and the FDA to expedite the process and enable a resubmission as soon as the corrective actions have been completed.”
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“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.