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81 stories matching this filter · ← front page

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  • Novo Nordisk's anti-inflammatory drug ziltivekimab fails to cut major heart events in Phase 3 trial
    Novo Nordisk reported that its investigational anti‑inflammatory antibody, ziltivekimab, did not reduce the incidence of major cardiovascular events in a pivotal Phase 3 study. The trial enrolled…
    STAT · 3h agoNegative readoutNegative↗ source
  • Novo Nordisk's ziltivekimab fails phase 3 trial, jeopardizing CKD program
    Novo Nordisk reported that its phase 3 Zeus trial of the IL‑6 ligand antibody ziltivekimab did not meet its primary endpoint, a setback for the drug's development. The study enrolled more than 6,3…
    Fierce Biotech · 7h agoNegative readoutNegative↗ source
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fda recalls22
fda press21
fda medwatch17
570
Vaccines507
Endocrinology & Metabolism289
Ophthalmology255
Infectious Disease252
Nephrology234
  • 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 · 1d agoRegulatoryNegative↗ source
  • Biogen CEO says company will pause new acquisitions and focus on developing existing pipeline
    Biogen's chief executive Christopher Viehbacher told analysts during the second-quarter earnings call that the company will slow its merger and acquisition activity for the foreseeable future. Aft…
    Fierce Biotech · 2d agoDealNeutral↗ source
  • Crystalys nets $130M more to push gout drug through late-stage tests
    The startup has a broad global development program underway — and the support of more than 20 investment firms — for a treatment that’s approved in many Asian countries but isn’t yet available in t…
    BioPharma Dive · 9d ago↗ source
  • Bristol Myers to build ‘powerful’ AI factory; Samsung Biologics bids for peptide maker
    Bristol Myers is the third pharmaceutical company to recently seek Nvidia’s help building a large AI data center. Elsewhere, a Novartis kidney drug gained a leg up on competitors.
    BioPharma Dive · 11d ago↗ source
  • Kolon’s cell-based gene therapy fails phase 3 osteoarthritis trial
    A phase 3 trial of Kolon TissueGene’s cell-based gene therapy has missed its co-primary endpoints. With a second late-stage study scheduled to report data in October, the biotech is holding off on…
    Fierce Biotech · 11d ago↗ 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 · 12d ago↗ source
  • Opinion: STAT readers on the value of primary care, obesity as a disease, and more
    “The real opportunity is to move beyond policies and narratives that pit specialties against one another,” presidents of the AAFP, ACP, and AAP write.
    STAT · 13d ago↗ source
  • Jasper gets a lifeline in merger with immune drugmaker Kira
    The acquisition, which involves a concurrent licensing deal with startup Mirador, gives Jasper a chance to rebound from setbacks that have wiped out most of its market value.
    BioPharma Dive · 14d ago↗ source
  • Dimerix buys a kidney injury drug; Arpeggio appears to be winding down
    Plus, news about Takeda, Novartis and Regenxbio. 🤝 Mission sells kidney injury drug to Dimerix: Dimerix will pay $5 million upfront for Mission’s Phase 2-ready candidate for acute kidney injury, k…
    Endpoints · 14d ago↗ source
  • Jasper finds new purpose in merger with Kira, while offloading Tavneos rival to Mirador
    Jasper Therapeutics is being reborn via a merger with Nasdaq-listed immune-mediated disease biotech Kira Pharmaceuticals.
    Fierce Biotech · 14d ago↗ source
  • STAT+: MDCalc is scoring the clinical calculators used by millions of doctors
    MDCalc is launching a quality-rating system for the more than 800 clinical calculators used to assess disease risk, transplant eligibility, and more.
    STAT · 14d ago↗ source
  • Dimerix snaps up Mission’s stalled, phase 2-ready kidney disease candidate in $292M deal
    Dimerix has bought an acute kidney injury drug from Mission Therapeutics, paying $5 million upfront and committing up to $287 million in milestones for the phase 2-ready asset.
    Fierce Biotech · 14d ago↗ source
  • Pete Hegseth’s announcement of annual testosterone screenings for service members divides medical experts
    Medical experts are divided on Defense Secretary Pete Hegseth’s announcement that U.S. service members will undergo annual testosterone screenings.
    STAT · 14d ago↗ source
  • Deaths from coronary artery disease have fallen, but more progress is within reach
    Managing risk factors is the key to further progress in reducing deaths from coronary artery disease, a new study finds.
    STAT · 16d ago↗ source
  • Nava Therapeutics emerges with $89M for lipid nanoparticles
    Nava Therapeutics, a secretive startup that’s been working on a new generation of lipid nanoparticles that target the bone marrow, immune cells and the kidney, has raised $89 million, the company t…
    Endpoints · 16d ago↗ source
  • STAT+: Pharmalittle: We’re reading about a battle between Lilly and Teva, psychedelic drugs, and more
    A U.S. appeals court revived a Teva Pharmaceuticals lawsuit accusing Eli Lilly of breaching ​an agreement allowing Teva to market a generic ‌version of Forteo
    STAT · 17d ago↗ source
  • STAT+: AIDS activists slam Biden R&D deal with Gilead over HIV prevention drug patents
    A group of AIDS activists obtained an R&D pact at the heart of a settlement between the U.S. government and Gilead Sciences over patents for HIV prevention.
    STAT · 17d ago↗ source
  • STAT+: Pharmalittle: We’re reading about an RFK Jr. push against psychiatric meds, a Sanofi blood cancer drug, and more
    U.S. health secretary Robert F. Kennedy Jr. is pressing forward with his effort to help Americans stop taking SSRI antidepressants
    STAT · 18d ago↗ source
  • STAT+: Pharmalittle: We’re reading about bigger drug discounts in Germany, drugmakers embracing secrecy, and more
    German lawmakers passed a bill that would more than double the discount on branded medicines drugmakers must provide the government
    STAT · 21d ago↗ source
  • Opinion: The primary care crisis paradox
    “Solving the health crisis in the United States will require confronting things far harder than readjusting a fee schedule.”
    STAT · 21d ago↗ source
  • STAT+: Pharmalittle: We’re reading about FDA commissioner contenders, a heart drug failure, and more
    The White House is reviewing a list of three top contenders for the FDA commissioner post
    STAT · 22d ago↗ source
  • STAT+: The quest to save Grace — and clear the way for rare disease patients everywhere
    How a father’s quest may shape the future of rare disease gene therapy.
    STAT · 22d ago↗ source
  • STAT+: RFK Jr. plans to create list of injuries caused by Covid-19 vaccines
    It's not clear what conditions may make the list, but outside experts are watching it closely.
    STAT · 22d ago↗ source