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2,332 stories matching this filter · ← front page

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  • Tyra Biosciences reports phase 2 bladder cancer data, complete response rates miss analyst targets, shares slide
    Tyra Biosciences disclosed early phase 2 results for its FGFR3‑selective inhibitor dabogratinib in patients with low‑grade, intermediate‑risk non‑muscle‑invasive bladder cancer. The trial evaluate…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Abbott receives FDA clearance for TactiFlex Duo catheter, offering flexible AFib ablation options
    Abbott announced that the U.S. Food and Drug Administration has cleared its new TactiFlex Duo catheter for use in atrial fibrillation ablation. The catheter can deliver pulsed field ablation, radi…
    Fierce Biotech · 1d agoRegulatoryPositive
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  • Beeline's oral lupus drug afimetoran meets primary endpoint in Phase 2, paving way for Phase 3
    Beeline Medicines announced that its oral small-molecule inhibitor afimetoran achieved the primary endpoint in a 48-week Phase 2 trial in patients with systemic lupus erythematosus (SLE). The tria…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • UK commission proposes new framework to regulate AI-driven medical tools
    A UK commission released a report on Thursday outlining 44 recommendations for how artificial intelligence should be governed in the medical sector. The guidance aims to capture AI's promise, such…
    STAT · 14h agoRegulatoryNeutral↗ source
  • Tyra Biosciences’ bladder cancer pill misses expected response rate in Phase 2 trial
    Shares of Tyra Biosciences dropped about 20% after data from its Phase 2 study of a bladder cancer pill fell short of market expectations. The experimental drug, dabogratinib, is taken daily and t…
    BioPharma Dive · 17h agoNegative readoutNegative↗ source
  • 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 · 21h 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 · 22h agoRegulatoryPositive↗ source
  • 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 · 23h 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 · 23h 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 to develop menin inhibitors for diabetes and cardiometabolic disease
    Caspian Therapeutics, a spin‑out from Kura Oncology, announced it is starting operations with $50 million in financing. The capital, led by BVF Partners and joined by Eli Lilly and Kura leadership,…
    STAT · 1d agoDealPositive↗ 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
  • AMA chief says AI will augment, not replace, physicians
    John Whyte, the chief executive of the American Medical Association, wrote an opinion piece asserting that artificial intelligence should work alongside doctors rather than take their place. He po…
    STAT · 1d agoPositive↗ source
  • Opinion: Autonomous AI could surpass AI-assisted doctors on key tasks by 2030
    The piece, authored by Ezekiel J. Emanuel and Abe Baker-Butler, argues that autonomous artificial intelligence is likely to outpace both unaided physicians and those using AI assistance on five cor…
    STAT · 1d agoNeutral↗ 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
  • Telemedicine firm begins offering GLP-1 medications to treat addiction
    A telemedicine company announced it will now prescribe GLP-1 class drugs to patients with substance-use disorders through its virtual platform. GLP-1 medications, originally approved for diabetes…
    STAT · 1d agoNeutral↗ 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
  • AI tools struggle to improve emergency room workflow, study finds
    The article notes that CEOs of leading AI firms have promised dramatic health benefits, but real‑world testing in emergency departments tells a different story. At Brigham and Women’s Hospital, th…
    STAT · 1d agoNegative↗ source
  • Two infants die in Pennsylvania measles outbreak, coroner confirms one death caused by virus
    Pennsylvania’s health coroner released details about two infant deaths that occurred during a growing measles outbreak in the state. The first infant, Ivan Miller, died on Aug. 14 shortly after bi…
    STAT · 15h agoNegative↗ 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