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314 stories matching this filter · ← front page

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  • Scaling delivery is key for CAR T therapies to succeed in autoimmune diseases
    Biopharma companies are exploring CAR T cell therapies as a potential cure for autoimmune disorders, a market that could be twice the size of oncology. While current treatments manage symptoms, the…
    BioSpace · 15h agoNeutral↗ source
  • Generate Bio drops as data accidentally leaked ahead of European conference
    Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
    BioSpace · 6h agoRegulatoryNeutral↗ source
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fda recalls56
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964
Psychiatry & CNS767
Ophthalmology459
Pain428
Endocrinology & Metabolism404
Infectious Disease384
  • Louisiana directs 20% of opioid settlement funds to sheriffs, who spend millions on police equipment
    KFF Health News investigated how Louisiana sheriffs used their share of opioid settlement money. The state allocated 20% of the settlement payouts to the 64 elected sheriffs, the largest law‑enfor…
    STAT · 12h agoNegative↗ source
  • Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging
    The Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device.
    fda medwatch · 17h ago↗ source
  • Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle Manifolds
    AVID Medical is correcting convenience kits containing Manifolds affected by the Medline Namic Angiographic Star Off Handle Manifold Recall.
    fda medwatch · 17h ago↗ source
  • Roche nabs expanded FDA approval for diagnostic tied to Jazz’s cancer drug
    Roche has been given an extended clearance by the FDA for its tests that can find patients eligible to use Jazz Pharmaceuticals’ oncology med Ziihera.
    Fierce Biotech · 17h ago↗ source
  • Flagship’s ProFound Therapeutics secures up to $35 M from Gates Foundation to discover preeclampsia drug targets
    Flagship Pioneering’s ProFound Therapeutics has entered a new partnership with the Gates Foundation that could provide up to $35 million for research. The agreement includes an initial $20 million…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System after sheath tip separation reports
    Boston Scientific announced a recall of its ENROUTE Transcarotid Neuroprotection System and the ENROUTE Transcarotid Neuroprotection System Plus. The FDA classified the recall as the most serious…
    fda medwatch · 1d agoCRLNegative↗ source
  • Oxford study finds Shingrix linked to lower risk of heart attacks, strokes and heart failure
    Researchers at Oxford University reported that receiving the newer shingles vaccine Shingrix was associated with a reduced risk of cardiovascular disease. The observation follows earlier work by t…
    STAT · 1d agoPositive readoutNeutral↗ source
  • Calcium scans may guide statin decisions in a few borderline patients, studies find
    Two recent trials evaluated whether coronary artery calcium (CAC) scans, used together with the PREVENT risk calculator, can help decide on statin therapy. The studies compared the imaging results…
    STAT · 1d agoNeutral↗ source
  • Trump’s Medicaid cuts strain rural hospitals in Maine and Louisiana
    President Trump’s administration has slashed about $1 trillion from projected Medicaid funding over the next ten years and let billions in insurance subsidies expire, prompting a rapid reassessment…
    STAT · 2d agoRegulatoryNegative↗ source
  • Labcorp introduces reflex hepatitis D test to improve detection of severe viral hepatitis
    Labcorp has launched a new hepatitis D (HDV) reflex testing option as part of its Comprehensive Hepatitis Testing portfolio, aiming to close a gap in HDV monitoring. The test automatically adds HD…
    Fierce Biotech · 2d agoPositive↗ source
  • Senators say HHS Secretary RFK Jr.’s Gardasil stake explanation contradicts earlier testimony
    A group of U.S. senators have raised concerns about the explanation offered by Robert F. Kennedy Jr., the Health and Human Services secretary, regarding how he disposed of a financial interest tied…
    STAT · 2d agoRegulatoryNegative↗ 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 · 2d agoLayoffsNegative↗ source
  • Roche and Eli Lilly receive FDA clearance for first blood test detecting Alzheimer’s biomarker pTau217
    Roche and Eli Lilly have secured FDA clearance for a new blood test that measures phosphorylated tau protein pTau217, a marker linked to amyloid plaques in Alzheimer’s disease. The Elecsys pTau217…
    Fierce Biotech · 3d agoApprovalPositive↗ source
  • FDA’s new leadership aims to restore reliability, but each application remains judged on its data
    The FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary. Recent actio…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Boehringer Ingelheim pauses Phase 1 study of oral candidate BI 3031185 after safety event
    Boehringer Ingelheim has placed a Phase 1 study of its oral candidate BI 3031185 on hold after a safety event was identified. The trial, run in Japan with healthy volunteers, was assessing tolerab…
    BioSpace · 3d agoCRLNegative↗ source
  • Handshakes in the ER: A simple gesture can ease patient anxiety
    An emergency medicine resident at Northwestern University recounts a recent shift where a patient faced a suspected oncologic emergency. The physician introduced herself with a handshake to the pat…
    STAT · 3d agoPositive↗ source
  • Nurse practitioner students struggle to find clinical preceptors, often paying thousands
    Nurse practitioner graduate programs require students to complete at least 500 hours of supervised patient care with a licensed preceptor. Across the United States, a shortage of qualified precepto…
    STAT · 3d agoNegative↗ source
  • Merck’s Ebola vaccine rolled out in the Democratic Republic of Congo
    Scientists have begun administering Merck’s Ebola vaccine in the Democratic Republic of Congo as part of ongoing outbreak response efforts. The vaccine, previously used in emergency settings, is b…
    STAT · 6d agoPositive↗ source
  • Novo Nordisk launches Phase 3 trial of lower maintenance doses of oral Wegovy for obesity
    Novo Nordisk has begun a Phase 3, placebo-controlled study called OASIS 5 to evaluate two lower oral doses of its GLP-1 weight-loss drug Wegovy (semaglutide) in people who are obese or overweight.…
    BioSpace · 6d agoCRLNeutral↗ source
  • New study shows focal therapy matches surgery and radiation survival while reducing side effects in localized prostate cancer
    Physicians remain split over focal therapy for localized prostate cancer, a technique that targets MRI‑visible lesions with heat, cold, or other energy sources instead of removing the entire gland.…
    STAT · 6d agoPositive readoutNeutral↗ source
  • Regeneron’s ultra-rare bone disorder drug receives U.S. approval after 30-year development
    Regeneron Pharmaceuticals announced that its therapy for an ultra-rare condition in which bone forms in soft tissue has been approved by the U.S. Food and Drug Administration. The disease, sometim…
    STAT · 7d agoApprovalPositive↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 7d agoApprovalPositive↗ source
  • Novo Nordisk leads early in oral obesity market, but analysts doubt lasting advantage
    Novo Nordisk's oral formulation of Wegovy generated DKK 3.22 billion (about $496 million) in revenue in the second quarter of 2026, far outpacing Eli Lilly's newly approved oral weight‑loss pill Fo…
    BioSpace · 8d agoNeutral↗ source