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655 stories matching this filter · ← front page

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  • Neurocrine’s rare-disease drug approved but later linked to deaths and serious side effects
    Neurocrine Biosciences received regulatory approval for a rare‑disease therapy after a small clinical trial showed modest efficacy and side effects that were considered manageable. The decision was…
    STAT · 2h agoRegulatoryNegative↗ source
  • Taiho and Cullinan's zipalertinib clears Phase 3 trial in EGFR-mutated lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their oral EGFR inhibitor zipalertinib successfully completed a registrational Phase 3 study in patients with a specific genetic form of lung…
    Endpoints · 2h agoPositive readoutPositive↗ source
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  • Zealand Pharma sells rights to rare blood cancer drug rusfertide for up to $100M
    Zealand Pharma entered a royalty purchase and sale agreement with Royalty Pharma, receiving $50 million upfront and the possibility of an additional $50 million after one year. In exchange, Zealan…
    BioSpace · 1h agoDealNeutral↗ source
  • New fertility options give young cancer survivors hope for parenthood
    Young cancer patients are facing increasing concerns about future fertility, prompting the growth of a specialty called oncofertility that blends oncology and reproductive medicine. One patient, J…
    STAT · 4h agoPositive↗ source
  • Avalyn Pharma CEO shares personal moment as company prepares for Nasdaq IPO
    Avalyn Pharma and Generate Biomedicines executives talked about the long hours and challenges of preparing their companies for an initial public offering. Avalyn CEO Lyn Baranowski highlighted a m…
    BioSpace · 6h agoPositive↗ 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 · 2h agoLayoffsNegative↗ source
  • Opinion: How to disrupt the health misinformation business model
    One way to fight medical misinformation: make it easier for people to understand when they are being manipulated, write Paul Martin Jensen and Avi Tuschman.
    STAT · 4h ago↗ source
  • STAT+: What patients actually think about ‘minimally invasive’ brain implants
    A new study polled people with treatment-resistant depression about what matters to them when it comes to brain implants for mental health.
    STAT · 4h ago↗ source
  • Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal
    Taiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing the partners up to challenge Johnson & Johnson for a lung can…
    Fierce Biotech · 7h ago↗ source
  • Zealand sells its rights to Takeda’s blood cancer drug for $100M ahead of FDA approval decision
    As the FDA mulls whether to approve Takeda and Protagonist Therapeutics’ rusfertide, Zealand Pharma has sold its own rights to the blood cancer drug in return for $100 million.
    Fierce Biotech · 8h ago↗ source
  • Replimune secures FDA approval for RP1 therapy in advanced melanoma as Eli Lilly reports strong Q2 earnings
    Replimune announced that the FDA has granted market approval for its oncolytic immunotherapy RP1, aimed at treating advanced melanoma. The decision follows two earlier rejections and a contentious…
    BioSpace · 1d agoApprovalPositive↗ source
  • Study finds cancer patients now wait longer for treatment than a decade ago
    A new analysis of more than 2.7 million cancer cases shows that the interval between diagnosis and the start of therapy has grown over the past ten years. The researchers examined records from a na…
    STAT · 22h agoNegative↗ source
  • AI monitoring tool could generate up to 82-fold ROI in phase-3 oncology trials, study finds
    An analysis by the Tufts Center for the Study of Drug Development found that an artificial-intelligence clinical monitoring agent can produce an estimated 82-fold return on investment in phase-3 on…
    Fierce Biotech · 23h agoPositive↗ source
  • WHO and DRC move to fast-track Phase 3 Ebola vaccine trial, starting with Merck’s Ervebo
    The World Health Organization and authorities in the Democratic Republic of the Congo are negotiating to speed up the launch of a multi‑armed Phase 3 trial of Ebola vaccines. The effort targets th…
    STAT · 16h agoCRLPositive↗ source
  • AI-focused biotech firms drive biopharma toward a 'fail-fast' drug development model
    AI is quickly becoming a central force in drug development as tech capital pours into biopharma, reshaping how new medicines are discovered. Tyrone Lam, chief business officer at GATC Health, says…
    BioSpace · 1d agoPositive↗ source
  • Climate change worsens symptoms for people with chronic illnesses, author reports from Chicago smoke events
    The author argues that climate change is already harming health, particularly for those living with chronic conditions, and that the impact is becoming more evident. She describes a recent summer…
    STAT · 1d agoNegative↗ source
  • Vaping and cannabis use hit record highs among U.S. young adults in 2025, survey finds
    A new national survey by the University of Michigan shows vaping and cannabis use among U.S. young adults reached record levels in 2025. Past‑30‑day nicotine vape use rose to 19%, more than triple…
    STAT · 16h agoNegative↗ source
  • Combination therapy including leronlimab clears HIV in infant macaques, offering new cure hope
    CytoDyn researchers tested leronlimab together with broadly neutralizing antibodies and antiretroviral therapy in a cohort of 55 infant macaques. Only the eight animals that received the full three…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Experts warn splitting MMR vaccine into separate shots could increase missed doses and illness
    The article notes that a recent executive order proposes separating the combined measles, mumps and rubella vaccine into three individual injections. The author argues that this change could lead t…
    STAT · 1d agoRegulatoryNegative↗ source
  • FDA issues complete response letter rejecting ITM Isotope's radiopharma therapy over manufacturing concerns
    FDA sent a complete response letter rejecting the NDA for ITM Isotope's investigational radiopharmaceutical, citing manufacturing and third-party facility issues. The agency said there were no con…
    BioSpace · 1d agoCRLNeutral↗ source
  • Former Legend Biotech chief Ying Huang named CEO of K2, targets $250 million Series A to license Asian assets
    Ying Huang spent the past seven years building one of the leading cancer cell‑therapy companies before stepping down as CEO of Legend Biotech. Weeks after announcing his departure, Huang has taken…
    Endpoints · 2d agoDealPositive↗ source
  • Swiss startup Vaderis raises $152 million to fund Phase 3 trial of rare bleeding disorder therapy
    Vaderis Therapeutics, a 13‑person Swiss biotech, announced a $152 million Series B financing round aimed at advancing its experimental therapy into a Phase 3 study. The company is testing a treatm…
    Endpoints · 2d agoDealPositive↗ source
  • FDA rejects ITM Isotope's radiopharmaceutical therapy over manufacturing problems, halting potential competitor to Novartis
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich SE, citing manufacturing deficiencies. The therapy was desig…
    STAT · 1d agoRegulatoryNegative↗ source
  • Aura Biosciences cuts 20% of staff and reshuffles C-suite to focus on ocular oncology
    Aura Biosciences announced it is eliminating about one-fifth of its workforce as part of a broader restructuring under its new chief executive officer, Natalie Holles, who took the helm in April.…
    Fierce Biotech · 2d agoLayoffsNeutral↗ source
  • Silence causes uproar in rare blood cancer space as data sets high bar for competitors
    The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Taked…
    BioSpace · 2d agoRegulatoryNeutral↗ source