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1,254 stories matching this filter · ← front page

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  • Kura Oncology launches Caspian Therapeutics to develop menin-inhibitor diabetes drug with $50M funding
    Kura Oncology has spun out a new biotech called Caspian Therapeutics to focus on menin inhibitors for diabetes and other cardiometabolic diseases. The company’s lead candidate, code-named KO-7246,…
    BioPharma Dive · 1d agoDealPositive↗ source
  • FDA appoints permanent heads of CDER and CBER, adding AI deputy role
    The Trump administration announced permanent appointments to two key FDA centers after a period of turnover. Michael Davis, who had been acting director of the Center for Drug Evaluation and Resea…
    BioPharma Dive · 1d agoRegulatoryPositive↗ source
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fda recalls70
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  • Webinar explores how GLP-1 obesity drugs are reshaping US healthcare and market dynamics
    The upcoming webinar titled "The Massive Scale of GLP-1s: Evolving Health, Healthcare and Markets" will examine how GLP-1 receptor agonists used for obesity are altering the U.S. health-care landsc…
    BioSpace · 1d agoNeutral↗ source
  • nPhase unveils AI-driven clinical data platform to accelerate trial design and submission
    nPhase, a clinical research organization, announced the launch of an end-to-end platform called nPhase.ai that uses artificial intelligence to manage clinical trial data. The platform includes a S…
    Fierce Biotech · 1d agoPositive↗ source
  • BMS reports positive mid-stage results for arlo-cel in heavily pre-treated myeloma patients
    BMS said its CAR T therapy arlo-cel, formally arlocabtagene autoleucel, achieved positive results in a registrational mid-stage study for relapsed and refractory multiple myeloma. The open-label,…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • Caspian Therapeutics launches with $50M funding and Eli Lilly backing to develop menin inhibitor for diabetes
    Caspian Therapeutics has been created as a spin-out from Kura Oncology to advance a menin-targeting drug for diabetes. The company received $50 million in initial capital, led by BVF Partners with…
    BioSpace · 1d agoDealPositive↗ source
  • Kura Oncology launches Caspian Therapeutics with $50M funding to develop next-generation diabetes drug
    Kura Oncology has created a new biotech called Caspian Therapeutics and secured $50 million in financing to advance a next-generation diabetes treatment. The spinout will focus on KO-7246, a highl…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Biopharma looks beyond China to five alternative overseas markets amid rising geopolitical tensions
    Geopolitical tensions between the United States and China are prompting biopharma companies to look beyond the Chinese market for growth. China remains the leading destination, with licensing deal…
    BioSpace · 1d agoNeutral↗ source
  • Biotech crossover rounds projected to exceed $4.2 billion in 2026, supporting IPO pipeline
    PitchBook forecasts that biotech crossover rounds could surpass $4.22 billion across roughly 28 rounds in 2026. The surge follows a market bottom after COVID and a rise in investor confidence, wit…
    BioSpace · 1d agoDealPositive↗ source
  • Labcorp acquires MLM Medical Labs to expand global lab network across four continents
    Labcorp, a major medtech and testing company, announced it has completed the acquisition of MLM Medical Labs. MLM operates central and specialty labs in the United States, Germany, and South Afric…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Solstice Oncology raises $225M Series A to push next-gen CTLA-4 antibody into Phase 2 colon cancer trial
    Solstice Oncology announced a $225 million Series A financing led by RA Capital Management, with participation from Canaan Partners and Forbion. The capital will fund the Phase 2 study of its Fc-e…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA appoints permanent heads of drug, biologics and tobacco centers and adds AI deputy commissioner
    The U.S. Food and Drug Administration announced permanent appointments for the leaders of its major product centers. The Center for Drug Evaluation and Research and the Center for Biologics Evalua…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA appoints permanent heads for CDER and CBER amid pending commissioner confirmation
    The Department of Health and Human Services announced that Michael Davis, MD, PhD, and Karim Mikhail will become the permanent directors of the Centers for Drugs Evaluation and Research and the Cen…
    Fierce Biotech · 1d agoRegulatoryNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 1d agoNeutral↗ source
  • FDA makes acting CBER and CDER heads permanent, signaling leadership continuity
    FDA promoted Michael Davis and Karim Mikhail from acting to permanent heads of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The ap…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 16h agoLayoffsNegative↗ source
  • Career setbacks offer data points, not definitive verdicts, says executive coach
    Angela Justice, an executive coach, describes how a sudden layoff can feel like a verdict but is really just a data point. She warns that people often turn the specific lesson from a setback into…
    BioSpace · 1d agoNeutral↗ source
  • Mass. governor makes pre-election pitch to biotechs amid warning early-stage start-ups are 'dying'
    It may have seemed like an ordinary Wednesday afternoon at MassBio’s headquarters in Technology Square, but the black SUV parked outside was a telltale sign that the Cambridge, Massachusetts-based…
    Fierce Biotech · 17h ago↗ source
  • Inhibrx’s OX40 agonist plus Keytruda shows 48% response rate, beating Keytruda alone in head and neck cancer Phase 2
    Inhibrx reported results from its Phase 2 HexAgon trial evaluating INBRX-106, an OX40 receptor agonist, combined with Merck’s Keytruda in patients with treatment‑naïve, PD‑L1‑positive metastatic or…
    BioSpace · 2d agoPositive readoutPositive↗ source
  • FDA grants accelerated approval to AstraZeneca’s Etcamah, enabling ctDNA-guided therapy for HR-positive breast cancer
    The FDA issued an accelerated approval for AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be sold as Etcamah, marking a rare departure from its advisory committee’s recomm…
    Fierce Biotech · 2d agoApprovalPositive↗ source
  • Novartis' $12 billion Avidity drug fails Phase 3 trial in myotonic dystrophy
    Novartis reported that its antibody-oligonucleotide conjugate del-desiran did not meet the primary endpoint in the Phase 3 HARBOR study for myotonic dystrophy type 1, showing no significant improve…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • AstraZeneca’s IL-33 antibody tozorakimab earns FDA priority review after COPD trial cuts exacerbations by up to 34%
    AstraZeneca’s R&D chief medical officer Sharon Barr said the company’s latest data on its IL-33 inhibitor represents an internal “science success story.” The results have earned the drug a priority…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • Boston Scientific recalls spinal cord stimulator leads after over 1,000 serious injuries
    Boston Scientific announced a recall of its Infinion CX spinal cord stimulation leads after the FDA classified the action as the most serious level. The recall, issued June 17, covers all unused l…
    Fierce Biotech · 2d agoCRLNegative↗ source
  • Roivant reports record-breaking Phase 2 results for PH-ILD drug mosliciguat, starts Phase 3
    Roivant announced that its experimental drug mosliciguat met all primary and secondary endpoints in a Phase 2 study in patients with pulmonary hypertension associated with interstitial lung disease…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
  • Structure Therapeutics reports oral GLP-1 weight-loss results comparable to Wegovy and strong Phase 1 amylin data
    Structure Therapeutics announced that its oral GLP-1 candidate aleniglipron achieved 72-week weight-loss results that BMO Capital Markets said were in line with Novo Nordisk’s oral Wegovy. Particip…
    BioSpace · 2d agoPositive readoutPositive↗ source