FDA issues a CRL for linvoseltamab’s BLA in R/R multiple myeloma that has progressed after at least three prior therapies
“The sole approvability issue identified is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company’s product candidate. The third-party fill/finish manufacturer has since informed Regeneron that it believes the findings have been resolved, their facility is awaiting reinspection by the FDA, and it is expected to take place in the coming months.”
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“Antengene announced it has entered into a global clinical collaboration with MSD to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. At the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2025), Antengene
“Advanced esophageal squamous cell carcinoma is a difficult-to-treat disease, and unfortunately overall survival remains low,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The initiation of the pivotal Phase 3 IDeate-Esophageal01 clinical trial demonstrates our shared commitment with Daiichi Sankyo to
“Overall response rate (ORR) was 97% (114/117) with a complete response/stringent complete response (CR/sCR) rate of 68% (79/117) and a very good partial response or higher (>VGPR) rate of 85% (100/117), per International Myeloma Working Group (IMWG) criteria as investigator-assessed. Of those evaluable for minimal residual disease (MRD) testing at
“EMA approval of the MIRACLE trial protocol is a huge milestone for us. Although we’re already seeing recruitment in our first non-EU country, we believe that this expansion into the EU really supercharges our recruitment potential,” said Walter Klemp, Chairman and CEO of Moleculin. “Importantly, when combined with the sites
