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156 stories matching this filter · ← front page

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  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 22h agoCRLNegative↗ source
  • Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
    Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product. The company said the contaminati…
    fda medwatch · 22h agoCRLNegative
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Psychiatry & CNS646
Endocrinology & Metabolism329
Ophthalmology328
Pain311
Infectious Disease302
↗ source
  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 1d agoNegative readoutNegative↗ source
  • Senate hearings blame China, not Fauci, for Covid-19 origin delays
    A Senate committee recently held a hearing on the origins of Covid-19 and concluded that Dr. Anthony Fauci was in contempt of Congress after invoking his Fifth Amendment rights. The author, a prof…
    STAT · 4d agoNegative↗ source
  • FDA approves first mRNA seasonal flu vaccine, mFlusiva, a year after funding cuts
    The U.S. Food and Drug Administration granted approval to mFlusiva, the first mRNA‑based seasonal influenza vaccine, after its advisory committee voted unanimously that the benefits outweigh the ri…
    STAT · 5d agoApprovalPositive↗ source
  • Only one third of US prostate cancer patients received pre-biopsy MRI in 2022, far below Western norms
    MRI is considered the standard pre-biopsy imaging tool for prostate cancer in most western nations, yet a new analysis shows that only about a third of US cases used it in 2022. In the United Stat…
    STAT · 6d agoNegative↗ source
  • Merck's anti-TL1A antibody shows benefit in hidradenitis suppurativa but misses endpoint in rare lung disease trial
    Merck reported mixed results from its anti‑TL1A antibody, a product of its $10.8 billion acquisition of Prometheus Biosciences. In a mid‑stage study for hidradenitis suppurativa, the antibody met…
    Endpoints · 7d agoNeutral↗ source
  • Merck to test experimental sac-TMT antibody-drug conjugate with Keytruda in lung cancer trial
    Merck announced it will start a clinical trial testing its experimental antibody-drug conjugate sac-TMT together with the immunotherapy Keytruda in patients with lung cancer. The study will assess…
    Endpoints · 7d agoNeutral↗ source
  • Lilly expands access to its experimental obesity therapy while Jazz pulls Zepzelca's second-line lung cancer use
    Lilly announced it will broaden the expanded‑access program for its obesity drug that has not yet received regulatory approval, allowing more patients to receive the treatment under a compassionate…
    raps · 8d agoRegulatoryNeutral↗ source
  • In-patient cardiac pre-hab program launched to keep heart-transplant candidates fit while awaiting surgery
    Patients waiting in the hospital for a heart transplant often lose strength and can become ineligible for the procedure as their fitness declines. To address this, Dr. Radha Gopalan at Banner‑Univ…
    STAT · 8d agoPositive↗ source
  • New York Senate advances assisted-dying bill as Nebraska Medicaid work rules spark coverage losses
    The New York Senate moved forward with legislation that would allow assisted dying, marking a significant step toward legalizing the practice in the state. In Nebraska, the recent implementation o…
    STAT · 8d agoNeutral↗ source
  • Medicaid work rules spark confusion over medically frail exemption, risking coverage for chronically ill
    Nebraska will begin enforcing Medicaid work requirements next week, demanding that beneficiaries work, volunteer or attend school for at least 80 hours each month or risk losing their health covera…
    STAT · 12d agoRegulatoryNegative↗ source
  • Biotech firms rush to develop gene-editing cure for rare alpha-1 antitrypsin deficiency
    A wave of biotech companies is intensifying efforts to cure alpha-1 antitrypsin deficiency (AATD), a rare liver and lung disorder, using gene-editing approaches. Companies such as Beam, Wave Life…
    STAT · 14d agoNeutral↗ source
  • New name for PCOS aims to boost awareness and diagnosis for Black and Latina women
    Bontle Moka-Moliki, a 32-year-old from Atlanta, was diagnosed with endometriosis in 2019, fibroids a year later, and in 2024 received a diagnosis of a condition now called polyendocrine metabolic o…
    STAT · 14d agoPositive↗ source
  • FDA advisory panel to decide on compounding of synthetic peptides amid safety concerns
    The FDA advisory committee is meeting to consider whether compounding pharmacies should be allowed to manufacture seven specific synthetic peptides. Use of these peptides has grown in the United St…
    STAT · 19d agoRegulatoryNeutral↗ source
  • FDA approves Nuvalent lung cancer drug shortly after GSK completes $10.6 billion acquisition
    The FDA announced Wednesday that it has approved a lung cancer medicine from Nuvalent, marking a key regulatory milestone for the biotech. The clearance arrived just a week after GlaxoSmithKline c…
    Endpoints · 20d agoApprovalPositive↗ source
  • Maui wildfire study proposes new rural health model for disaster recovery
    Researchers Alika Maunakea and Ruben Juarez are leading one of the largest investigations into the long‑term health effects of the 2023 Lahaina wildfires. The study follows more than 20 participant…
    STAT · 20d agoPositive↗ source
  • Pharma pushes back on China restrictions as AI VC raises $800M and Merck unveils cholesterol pill; Celldex reports trial setback
    Pharma companies are working to ease the impact of broad new restrictions in China, seeking ways to maintain market access amid tighter regulatory scrutiny. An AI‑focused venture capital firm anno…
    STAT · 20d agoNeutral↗ source
  • Opinion warns post-pandemic polarization may lock in false lessons from Covid response
    The authors, Marc Lipsitch and Sara Cody, argue that the public and policymakers are drawing misleading conclusions from the Covid-19 pandemic. They point out that early nonpharmaceutical interven…
    STAT · 21d agoNegative↗ source
  • Physician blames U.S. health insurance failures after husband's suicide
    Joy Evers, an emergency physician, recounts the death of her husband Randy by suicide, describing how she expected her family’s high-quality commercial health insurance to ensure he received timely…
    STAT · 22d agoNegative↗ source
  • Opinion: Beware the unintended consequences of testosterone screening for military servicemembers
    “I fear that the widespread rollout of testosterone screening may lead to some surprising and unintended consequences,” writes a urologist who studies testosterone.
    STAT · 24d ago↗ source
  • Opinion: What the 20th-century war on smog tells us about today’s wildfire smoke
    The evolution of air pollution policy shows how to respond to the dangerous haze caused by Canadian wildfires, experts write in opinion piece.
    STAT · 25d ago↗ source
  • Quitting smoking is hard. A Medicare change may push doctors to give more help
    Physicians who offer counseling on quitting cigarettes and alcohol during patient visits would get a 19% increase in reimbursement under a proposed Medicare change.
    STAT · 25d ago↗ source
  • STAT+: Celcuity’s breast cancer drug approved, its first
    FDA's new CBER chief promises normalcy, an weight loss drug without GLP-1s, and more biotech news from The Readout
    STAT · 27d ago↗ source
  • STAT+: Akero team, backed by Fairmount, launches new immunology company
    FDA approves injectable Leqembi, another post-Makary reversal, and other biotech news from The Readout
    STAT · 28d ago↗ source