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CStone's CS2009 Secures U.S. FDA IND Clearance for Phase II Trial in Advanced Solid Tumours
CStone Pharmaceuticals has received U.S. FDA IND clearance to begin a Phase II trial of its trispecific antibody CS2009 for advanced solid tumours, advancing its global immunotherapy development programme.
FDA Grants Orphan Drug Status to HanchorBio's HCB101 for Gastric Cancer
The Orphan Drug Status designation to HanchorBio supports development of next-generation CD47–SIRPα immunotherapy for advanced gastric adenocarcinoma across HER2-positive and HER2-negative subtypes.
HeriCare-Breast01 study evaluates next-generation HER2 ADC against standard THInnovent BiologicsP regimen, following promising phase I/II efficacy and safety data presented at ASCO 2025.
STADA and Bio-Thera Secure EU Marketing Approval for Golimumab Biosimilar Gotenfia
European Commission authorises Gotenfia, referencing Simponi, for multiple autoimmune diseases across EU and EEA markets.
US Food and Drug Administration has accepted the supplemental New Drug Application submitted by Biofrontera for its photodynamic therapy product Ameluz, used with the RhodoLED red-light lamp system, for the treatment of superficial basal cell carcinoma.
Dewpoint Therapeutics Inc advances MYC small molecule toward oncology development manufacturing
Dewpoint Therapeutics Inc., a biotechnology company developing condensate-modulating medicines, has selected a development candidate for its MYC oncology programme, marking a key step toward advancing a first-in-class small molecule designed to regulate MYC-driven cancer biology.
Median Technologies, a France-based developer of artificial intelligence-powered software as a medical device, has entered a non-exclusive distribution agreement with Tempus AI, Inc. to commercialise its Eyonis LCS lung screening platform in the United States.
Daiichi Sankyo Submits sNDA in Japan for Datroway in First-Line Metastatic TNBC
Daiichi Sankyo files supplemental application in Japan for Datroway as a first-line treatment for metastatic triple negative breast cancer based on phase III trial data.
THX Pharma and Biocodex Sign Licensing Deal for Rare Disease Drug Candidates
Biocodex secures global rights to Batten-1 and North American rights to TX01 from THX Pharma in a deal worth up to Euro 173 million to advance treatments for juvenile Batten disease, Gaucher disease and Niemann-Pick type C.
SOFIE Biosciences doses first patient in Phase III FAPI-PRO trial for pancreatic cancer imaging
SOFIE Biosciences has dosed the first patient in its Phase III FAPI-PRO trial evaluating 18F-FAPI-74 PET/CT for detecting metastatic pancreatic ductal adenocarcinoma, with 18 sites planned across 24 months.
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