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3,187 stories matching this filter · ← front page

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  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 28d agoRegulatoryNegative↗ source
  • STAT AI Prognosis newsletter tackles AI doomerism and offers guidance for health professionals
    The latest web edition of STAT’s AI Prognosis newsletter, authored by health tech reporter Brittany Trang, focuses on the growing chatter around AI doomerism. It aims to help readers cut through th…
    STAT · 28d agoNeutral↗ source
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fda medwatch93
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Nephrology645
  • Opinion: Mentally ill women need stronger support to become mothers
    Meg LeDuc writes in an opinion piece that maternal mental-health needs of women with serious psychiatric conditions have been largely ignored in the United States. She recounts her own history of…
    STAT · 29d agoPositive↗ source
  • Amgen reports positive Phase 3 results for Sjögren's drug; Novartis announces $900M radioligand partnership
    Amgen said its CD40 ligand antagonist dazodalibep met the primary endpoint in a Phase 3 trial for Sjögren's syndrome, marking a notable achievement for the company. Novartis disclosed a $900 milli…
    Endpoints · 29d agoPositive readoutPositive↗ source
  • Consumer groups call on FDA to strengthen generic drug testing and safety reporting under GDUFA IV
    Consumer health organizations used a public meeting on the reauthorization of the Generic Drug User Fee Amendments to press the FDA for more resources dedicated to testing generic medicines. The g…
    raps · 1mo agoRegulatoryNegative↗ source
  • HHS rolls out new FDA rule to allow non-animal testing methods in drug development
    The Department of Health and Human Services announced a new set of strategies aimed at shifting drug development away from animal testing toward human-based research methods. The FDA issued a fina…
    STAT · 29d agoRegulatoryPositive↗ source
  • US officials launch probe into falling German drug prices amid EU pharma push for competitiveness
    US trade officials held a hearing on Tuesday about a possible investigation into the decline in Germany's payments for pharmaceuticals. Testimony presented arguments both supporting and opposing t…
    Endpoints · 29d agoRegulatoryNeutral↗ source
  • Former FDA Commissioners Endorse Heidi Overton as Strong Choice to Lead Agency
    Two former FDA commissioners, Scott Gottlieb and Mark B. McClellan, wrote an opinion piece supporting Heidi Overton’s nomination to lead the agency. They note her confirmation hearing is set before…
    STAT · 29d agoRegulatoryPositive↗ source
  • Vertex reports early kidney drug data, boosting hopes for broad label ahead of next year's pivotal readout
    Vertex Pharmaceuticals disclosed early data from its experimental kidney disease therapy inaxaplin, showing improvements on a urine-based biomarker. The drug demonstrated positive changes in two s…
    Endpoints · 29d agoPositive readoutPositive↗ source
  • Celldex's barzolvolimab meets Phase 3 goals but safety concerns emerge
    Celldex announced that its experimental chronic hives treatment, barzolvolimab, achieved the primary endpoint in two Phase 3 trials. The trials demonstrated the drug's efficacy in reducing hive sy…
    Endpoints · 29d agoPositive readoutNeutral↗ source
  • Nvidia-backed Iambic Therapeutics files for IPO, unveils AI-driven pipeline
    Iambic Therapeutics, a San Diego biotech that uses artificial intelligence to discover medicines, announced it has filed a registration statement to become a publicly traded company. The filing ma…
    Endpoints · 29d agoDealNeutral↗ source
  • Novo Nordisk may secure more favorable terms under Medicare’s Bridge obesity drug program
    Novo Nordisk and Eli Lilly have been profiting from a Medicare pilot that caps obesity drug prices for seniors at $245 a month. Recent analysis suggests Novo could negotiate an even better arrangem…
    STAT · 29d agoRegulatoryPositive↗ source
  • Roche presents positive Phase 2 results for enicepatide in overweight and obese type 2 diabetes patients
    Roche has released new data from a Phase 2 trial of enicepatide, a peptide acquired from Carmot Therapeutics, focusing on overweight or obese adults with type 2 diabetes. The trial met its primary…
    Endpoints · 29d agoPositive readoutPositive↗ source
  • GOP health policy guru continues to support $1 trillion Medicaid cuts, warning of next target
    Brian Blase, president of the Paragon Health Institute, has become a trusted adviser to Republican lawmakers and has publicly defended sweeping Medicaid reductions. The One Big Beautiful Bill Act,…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA issues third warning letter to Empower Pharmacy over GLP-1 weight-loss treatments
    The U.S. Food and Drug Administration sent a formal warning letter to Empower Pharmacy, a compounder based in Houston, concerning its GLP-1 weight-loss products. The notice marks the company's thi…
    Endpoints · 29d agoRegulatoryNegative↗ source
  • Trump Medicaid pricing plan may give Novo Nordisk unexpected financial boost
    STAT reports that the White House introduced a plan aimed at lowering the cost of drugs for Medicaid beneficiaries. The policy includes provisions that reduce prices of obesity treatments for senio…
    STAT · 29d agoRegulatoryNeutral↗ source
  • Western pharma firms lobby Trump administration to preserve China partnership opportunities
    Western pharmaceutical companies are urging the Trump administration to permit continued collaborations with Chinese firms on promising drug candidates, despite a 2025 law that limits U.S. investme…
    STAT · 29d agoRegulatoryNeutral↗ source
  • Federal AI Initiative Aims to Improve Chronic Heart Failure Care, Pending Doctor and Patient Acceptance
    A new federal program will test artificial‑intelligence tools in the management of chronic heart‑failure patients. The initiative is designed to explore how AI can support diagnosis, monitoring and…
    Endpoints · 29d agoNeutral↗ source
  • Novo CEO acknowledges need to rebuild investor confidence after muted capital markets day
    Novo held a capital markets day on Monday in London, where the company outlined its strategy. Investors said the presentation left them underwhelmed. CEO Mike Doustdar acknowledged the reaction, s…
    Endpoints · 29d agoNegative↗ source
  • Regulators Share Guidance for Effective Sponsor Meetings
    Regulators from the U.S. FDA, the U.K. MHRA and other European agencies met to outline best practices for sponsor‑regulator interactions. They highlighted that transparency, open collaboration, at…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Global regulators must align on new approach methodologies to give sponsors certainty
    New approach methodologies, or NAMs, are being promoted as ways to reduce reliance on animal testing in drug development. They promise faster, more humane studies while still providing safety data.…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Pharma firms ask Trump admin to safeguard China partnerships as EU pushes for quicker trials and higher spending
    Pharma companies in the United States are urging the Trump administration to take steps that would protect their existing and future business arrangements with Chinese partners. At the same time,…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Insurers Begin Accelerating AI Adoption After Lagging Behind Providers
    Insurers have traditionally been slower than health-care providers in adopting artificial intelligence tools, but the gap is narrowing. A growing share of insurers now say they plan to significant…
    Endpoints · 29d agoPositive↗ source
  • STAT Health Tech newsletter highlights Epic's AI mortality model and Omada's upcoming products
    The latest STAT Health Tech newsletter edition spotlights two developments in health technology. It reviews Epic Systems' new mortality prediction algorithm, an artificial intelligence tool design…
    STAT · 29d agoNeutral↗ source
  • Integrative Oncology Proven to Ease Cancer Symptoms, Yet Insurance Still Refuses Coverage
    Professor Lorenzo Cohen, a distinguished integrative oncology researcher and melanoma survivor, argues that the science supporting symptom-relieving therapies for cancer patients is well establishe…
    STAT · 1mo agoNegative↗ source