FDA Approves Promega OncoMate® MSI Dx Analysis System as Companion Diagnostic for KEYTRUDA® Plus LENVIMA® in Advanced Endometrial Carcinoma The U.S. Food and Drug Administration (FDA) has officially approved the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic…
PharmaEssentia USA Appoints Dr. Barry Flannelly as Independent Director, Strengthening Leadership Amid Expanding Global Ambitions PharmaEssentia USA Corporation, a wholly owned subsidiary of PharmaEssentia Corporation (TWSE: 6446), today announced the appointment of Barry Flannelly, Pharm.D., MBA, as an Independent Director…
Kardigan Showcases Positive Phase 2 Data for Ataciguat in Moderate Calcific Aortic Valve Stenosis at AHA Scientific Sessions 2025 Kardigan, a cardiovascular-focused biotechnology company working to modernize drug development for heart disease, announced encouraging new Phase 2 results for its…
Aulos Bioscience Unveils Encouraging New Phase 2 Data Highlighting Imneskibart’s Clinical Activity in Melanoma and Non–Small Cell Lung Cancer Aulos Bioscience, a clinical-stage immuno-oncology company advancing next-generation immune-modulating therapies, has presented promising new clinical data from its ongoing Phase 2…
Gilead Shares Update on Phase 3 ASCENT-07 Trial Evaluating Trodelvy in HR+/HER2-Negative Metastatic Breast Cancer Gilead Sciences, Inc. (Nasdaq: GILD) has released new clinical findings from its Phase 3 ASCENT-07 study evaluating Trodelvy® (sacituzumab govitecan-hziy) as a first-line treatment following…
enGene Honored by BioSpace as a 2026 Best Place to Work, Underscoring Strong Culture and Mission-Driven Innovation enGene Holdings Inc. (“enGene” or the “Company”) (Nasdaq: ENGN), a clinical-stage, non-viral genetic medicines company, announced that it has been named to the…
Zoetis Appoints Kevin Esch as New R&D President to Succeed Rob Polzer in 2026, Marking a Strategic Leadership Transition in Global Animal Health Innovation Zoetis Inc. (NYSE: ZTS), the world’s leading animal health company, announced a major leadership transition in…
DoseMe Expands Precision Dosing Leadership with Strategic Acquisition of Firstline to Deliver Comprehensive Clinical Decision Support in the Global Fight Against Infectious Diseases DoseMe, a global leader in model-informed precision dosing (MIPD) software and a portfolio company of Fairlong Capital,…
Lupin Digital Health Launches VITALYFE™, an AI-Powered Platform to Boost Heart Health for India’s Workforce Lupin Digital Health, India’s leading cardiac digital-therapeutics company, today announced the launch of VITALYFE™, an AI-powered cardiometabolic wellness platform designed to help India’s working professionals…
Almost 1/3 Eyeing Job Options Outside US, BioSpace Finds Nearly one-third of biotech and pharma professionals are thinking about leaving the U.S. to find biopharma jobs, according to a BioSpace LinkedIn poll. Career coaches discuss why people are considering relocating and what they should…
FDA Formally Rejects Regeneron’s Eylea HD Over Manufacturing Issues. Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing…
FDA Struggles to Keep Lights On Amid Shutdown as Biopharmas Begin To See Delays While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn…
