Amgen has acquired United Kingdom-based Dark Blue Therapeutics Ltd. in a deal valued at up to $840 million, adding a first-in-class preclinical asset to its early oncology pipeline. The investigational small molecule, designed to degrade MLLT1 and MLLT3 proteins, targets transcriptional dependencies in acute myeloid leukemia. With preclinical data suggesting anti-leukemic activity and mechanistic differentiation,
Incyte Corporation has announced positive topline results from its Phase 3 frontMIND trial evaluating tafasitamab (marketed as Monjuvi/Minjuvi) and lenalidomide in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint of progression-free survival (PFS) and a key secondary endpoint of event-free survival (EFS), setting the stage for
GSK PLC (LSE/NYSE: GSK) has received regulatory approval from the National Medical Products Administration of China for Nucala (mepolizumab) as an add-on maintenance therapy for adults with eosinophilic chronic obstructive pulmonary disease (COPD) inadequately controlled on inhaled triple therapy. The greenlight marks a strategic respiratory expansion for GSK in the world’s largest COPD market and
GenEditBio Limited, a Hong Kong–headquartered clinical-stage biotechnology firm focused on in vivo genome-editing therapies, announced that the United States Food and Drug Administration has cleared its Investigational New Drug application for GEB‑101, a CRISPR-based candidate for TGFBI corneal dystrophy. This regulatory milestone authorizes the launch of the Phase 1/2 CLARITY trial in the United States,
Island Pharmaceuticals Limited has confirmed that the United States Food and Drug Administration (FDA) continues to evaluate its most recent regulatory submission related to Galidesivir, the company’s clinical-stage antiviral candidate being advanced under the Animal Rule pathway. In correspondence dated 2 January 2026, the regulator informed the Australian biotech firm that additional time is required
Johnson & Johnson (J&J) announced that its investigational candidate JNJ-95475939 (JNJ-5939) failed to meet prespecified efficacy criteria in the DUPLEX-AD Phase 2b trial for moderate to severe atopic dermatitis. Following an interim analysis, the study was terminated early. Despite showing a favorable tolerability profile, the molecule did not demonstrate sufficient clinical efficacy to warrant continuation.
HUTCHMED (China) Limited announced on December 29, 2025, that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for fanregratinib (HMPL-453) with priority review for second-line treatment of adult patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement. The NDA submission is based on a Phase II registration study in China
Curasight A/S has dosed the first patient in a Phase 1 clinical trial of uTREAT for glioblastoma, launching the therapeutic half of its uPAR-targeting theranostic platform alongside its companion diagnostic, uTRACE, which is already in Phase 2 for prostate cancer. How curative ambitions shift when a theranostic platform enters human testing in glioblastoma Curasight’s advancement
mAbxience and Amneal Pharmaceuticals have secured U.S. Food and Drug Administration (FDA) approval for two denosumab biosimilars, Boncresa and Oziltus, referencing Prolia and XGEVA respectively, clearing a long-anticipated regulatory hurdle in osteoporosis and oncology supportive care. The approvals position Amneal Pharmaceuticals as the exclusive U.S. commercial partner, with mAbxience responsible for development and manufacturing, marking
Find out how Diamyd Medical is accelerating its type 1 diabetes Phase 3 trial after FDA alignment—what this means for approval, adoption, and risk.