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2,277 stories matching this filter · ← front page

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  • Eli Lilly moves to curb black-market sales of retatrutide amid rising illicit demand
    Eli Lilly announced steps to address the growing black‑market trade of its obesity/diabetes drug retatrutide, which has seen increasing illicit use. The company is working with law‑enforcement and…
    STAT · 20h agoRegulatoryNegative↗ source
  • Aligned Marketplace secures $20 million to link self-insured employers with primary-care clinics
    Aligned Marketplace is a health‑tech startup that matches self‑insured employers with primary‑care clinics, helping companies provide direct access to medical services for their workers. The compa…
    Endpoints · 22h agoDealPositive↗ source
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  • 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 · 1d agoPositive↗ source
  • Zealand Pharma sells its rights to Takeda's rusfertide for $100 million ahead of FDA decision
    Zealand Pharma has agreed to sell its economic interest in rusfertide, a peptide drug being developed by Takeda and Protagonist Therapeutics, for $100 million. The transaction comes as the FDA rev…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • STAT+ probes Commure’s AI-driven health-care platform and Medicare’s new incentives for AI medical devices
    The STAT Health Tech newsletter edition dated Aug 13, 2026 features an investigative piece on Commure, a General Catalyst-backed firm that claims to automate health-care operations using artificial…
    STAT · 22h agoNeutral↗ source
  • California’s new CalRx insulin label aims for affordable access but faces slow rollout
    California launched a state‑branded insulin label, CalRx, this year to provide lower‑cost insulin to patients without insurance. The pens, marked with the state’s grizzly bear logo, are now stocked…
    STAT · 1d agoNeutral↗ source
  • European trade group urges authorities to grant notified bodies access to Eudamed for risk-based oversight
    A trade association representing notified bodies has formally asked EU regulators to allow them to access the Eudamed database. The group says that such access would enable them to apply the risk-…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA releases draft PDUFA VIII commitment letter outlining goals and enhancements for 2028-2032
    The FDA on Thursday issued a proposed commitment letter for the upcoming PDUFA VIII cycle, which will cover fiscal years 2028 through 2032. The letter sets out the agency's performance targets for…
    raps · 1d agoRegulatoryNeutral↗ source
  • Epilepsy drug from Ovid and Takeda receives fresh start under Perceptive-backed venture
    After about 26 months since two Phase 3 trials failed, the epilepsy treatment candidate originally developed by Ovid Therapeutics and Takeda has been removed from their pipelines. Investment firm…
    Endpoints · 16h agoDealNeutral↗ source
  • Health secretary Kennedy pushes new addiction-treatment strategy in California, criticizes prior administration
    Health secretary Robert F. Kennedy Jr. traveled to California to present the Biden administration’s revised plan for addiction treatment, following a recent White House initiative on vaccine policy…
    STAT · 20h agoRegulatoryNeutral↗ source
  • Patients with treatment-resistant depression weigh pros and cons of brain-implant devices
    A new study surveyed individuals with treatment-resistant depression about their preferences and concerns regarding implantable brain devices aimed at alleviating mood symptoms. Respondents highli…
    STAT · 1d agoNeutral↗ source
  • Commure ends referral payment program for its AI clinic tools
    Commure, a health-software firm valued at about $7 billion, announced it is ending the referral-payment arrangements it had with partners who promoted its artificial-intelligence products to medica…
    STAT · 13h agoNeutral↗ 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 up the partners to challenge Johnson & Johnson in a lung canc…
    Fierce Biotech · 1d agoNeutral↗ source
  • Definium's LSD pill shows positive results in late-stage anxiety trial
    Definium Therapeutics reported that its pharmaceutical-grade LSD formulation, DT120, achieved positive outcomes in a late-stage study targeting generalized anxiety disorder. The trial used a 56-po…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
  • Experts warn of deaths linked to Neurocrine's Vykat XR for Prader-Willi syndrome
    A coalition of specialists in Prader-Willi syndrome has raised serious concerns about the safety profile of Neurocrine Biosciences' drug Vykat XR. The experts point to a series of adverse events,…
    Endpoints · 1d agoRegulatoryNegative↗ 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 · 1d agoNegative↗ source
  • Neurocrine's Prader-Willi drug Vykat XR linked to multiple deaths and serious side effects
    A group of physicians and experts in Prader-Willi syndrome warned clinicians about safety concerns with Vykat XR, a drug approved by the FDA in March 2025 to reduce the intense hunger in patients w…
    STAT · 2d agoRegulatoryNegative↗ 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 · 1d agoPositive↗ source
  • Former Pfizer chemist launches Khartis Therapeutics with $95M to develop oral thyroid eye disease drug
    Robert Hoffman, a veteran Pfizer chemist who previously co‑founded XinThera, announced the launch of Khartis Therapeutics. The new company, formed in 2024 with other former XinThera leaders, aims t…
    Fierce Biotech · 1d agoDealPositive↗ source
  • AbCellera, Silence and InduPro secure major funding rounds as AbCellera completes $200M share sale
    Vancouver based biotech AbCellera announced a $200 million share offering after meeting its efficacy targets in a Phase 2 hot flashes trial. The capital raise follows the company achieving its pred…
    Endpoints · 1d agoDealPositive↗ source
  • Definium's LSD pill shows significant anxiety reduction in Phase 3 trial
    Definium Therapeutics announced results of a Phase 3 trial testing its LSD‑based pill DT120 in patients with generalized anxiety disorder. The study enrolled 214 participants who received a single…
    STAT · 1d agoPositive readoutPositive↗ 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 · 1d agoCRLPositive↗ source
  • Fifth Circuit Court Rules in Favor of Providers on No Surprises Act Arbitration, May Increase Payments
    The U.S. Court of Appeals for the Fifth Circuit issued a decision that sides with health-care providers in a lawsuit over the No Surprises Act. The case stemmed from a 2022 Texas Medical Associati…
    STAT · 1d agoRegulatoryPositive↗ source
  • WHO calls Trump’s vaccine policy order misguided, warns it could increase needle shots and disease risk for children
    WHO Director-General Tedros Adhanom Ghebreyesus and other senior officials criticized a new U.S. executive order that seeks to overhaul the childhood vaccination schedule. The order, signed by Pre…
    STAT · 1d agoRegulatoryNegative↗ source
  • FDA outlines new onshoring incentives and meeting types for generic drug applicants under GDUFA IV
    The FDA released its GDUFA IV commitments, indicating that review timelines for generic drug submissions will remain largely consistent through 2032, mirroring the schedule of the previous five yea…
    Endpoints · 1d agoRegulatoryNeutral↗ source