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34 stories matching this filter · ← front page

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  • Supernus and Indivior merge to form CNS-focused company with 11 marketed drugs and $2.2B revenue target
    Supernus Pharmaceuticals and Indivior Pharmaceuticals announced an all‑stock merger of equals, creating a central nervous system‑focused company that will combine their product lines and operations…
    BioSpace · 2h agoDealPositive↗ source
  • Novo Nordisk’s Phase 3 failure of IL-6 drug ziltivekimab rattles inflammation-focused pipeline
    Novo Nordisk reported that its late-stage IL-6 inhibitor ziltivekimab did not achieve its primary goal in the Phase 3 ZEUS trial, which was designed to lower cardiovascular complications. The disa…
    BioSpace · 5h agoNegative readoutNegative↗ source
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32
fda recalls25
fda press21
fda medwatch18
589
Vaccines519
Endocrinology & Metabolism300
Ophthalmology269
Infectious Disease256
Nephrology240
  • Neurologist Who Diagnoses ALS Patients Receives Own Diagnosis, Reflects on Impact of Disability
    Dr. Christopher Campos, a neurologist and assistant professor at UC Davis Health, disclosed that he was diagnosed with amyotrophic lateral sclerosis (ALS) in 2025 after a decade of delivering the s…
    STAT · 8h agoNegative↗ source
  • AbbVie shares slip 4% as Q2 immunology earnings beat falls short of lofty expectations
    AbbVie’s stock fell about 4% on Friday after the company reported second‑quarter results that modestly exceeded analyst forecasts, disappointing investors who had set very high expectations. The f…
    BioSpace · 3d agoEarningsNegative↗ source
  • Biogen’s early Phase 2 data supports tau-targeting Alzheimer’s approach
    Biogen has released early Phase 2 results for its experimental Alzheimer’s therapy diranersen, indicating that reducing tau protein levels may lead to cognitive benefits. The findings add to a lon…
    BioSpace · 4d agoPositive readoutPositive↗ source
  • Arvinas CEO outlines strategy to rebuild pipeline after lead asset departure
    In a recent episode of the Denatured podcast, Arvinas President and CEO Randy Teel discussed how the company is shifting focus to an early‑stage pipeline after its lead asset was out‑licensed or di…
    BioSpace · 4d agoPositive↗ source
  • Four biotech firms secure Series B funding and open new hiring opportunities
    Biotech companies that closed Series B financing rounds this year are actively recruiting as they expand their operations. Atavistik Bio, based in Cambridge, Massachusetts, announced a $40 million…
    BioSpace · 4d agoDealPositive↗ source
  • FDA advisory panel votes 9-3 against Capricor's Duchenne therapy deramiocel
    During an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting, reviewers focused on the Phase 3 HOPE-3 trial's secondary cardiac endpoint and described the data as very fragile. The…
    BioSpace · 4d agoApprovalNegative↗ source
  • FDA advisory panel votes 9-3 against approval of Capricor’s Duchenne muscular dystrophy therapy deramiocel
    The FDA Cellular, Tissue, and Gene Therapies Advisory Committee focused heavily on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, describing the data as very fragile. Committee…
    BioSpace · 4d agoRegulatoryNegative↗ source
  • Kyverna partners with ElevateBio to supply its autologous CAR-T therapy for autoimmune launches
    Kyverna Therapeutics has signed a five‑year manufacturing agreement with contract development and manufacturing organization ElevateBio. The deal makes ElevateBio the primary supplier of Kyverna's…
    BioSpace · 5d agoDealPositive↗ 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 · 5d agoLayoffsNegative↗ source
  • Dementia finally shows a viable business model, AAIC2026 highlights economic shift
    At the Alzheimer’s Association International Conference in London this year, the author observed that dementia now appears to have a clear business model, a shift from earlier meetings where commer…
    STAT · 6d agoPositive↗ source
  • Otsuka receives FDA approval for Simtriyo, first norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD
    Otsuka Pharmaceutical announced that the FDA has approved its daily pill centanafadine, branded as Simtriyo, for the treatment of attention-deficit hyperactivity disorder in patients six years and…
    BioSpace · 7d agoApprovalPositive↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
    BioSpace · 10d agoDealNeutral↗ source
  • How Kyverna rode CAR T’s autoimmune wave to the FDA’s door
    Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
    BioSpace · 14d ago↗ source
  • Bryan Johnson’s chronic disease is notoriously difficult to diagnose
    Why longevity entrepreneur Bryan Johnson’s chronic disease is notoriously difficult to diagnose.
    STAT · 26d ago↗ source
  • Opinion: STAT+: What’s the right role for AI in dementia care?
    Three tricky questions about using AI in dementia care.
    STAT · 26d ago↗ source
  • STAT+: FDA appears open to Moderna’s flu vaccine ahead of adcomm
    UniQure will submit Huntington's therapy for approval, Eli Lilly buys 4E Therapeutics, and more biotech news
    STAT · 1mo ago↗ source
  • STAT+: Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval
    The FDA has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its maker.
    STAT · 1mo ago↗ source
  • STAT+: A prominent VC explains why she’s against U.S. restrictions on investment in China’s drug industry
    Should the federal government try to slow — or even block — U.S. biotech deals that could benefit China?
    STAT · 1mo ago↗ source
  • The U.S. infant mortality rate fell to an all-time low, though it still trails other similar nations
    Infant mortality in the U.S. dropped to a new all-time low in 2025, according to CDC data, though it still trails other similar nations.
    STAT · 1mo ago↗ source
  • STAT+: ARCH-launched Neumora stops depression program
    A new AI model to improve trial enrollment, importing drugs from Canada, and more biotech news from The Readout
    STAT · 1mo ago↗ source
  • STAT+: Verge Labs’ new AI model solves patient stratification problems for neurology clinical trials
    As the saying goes, one man’s trash is another man’s treasure. Or as Verge Labs might put it, one company’s failed clinical trial … is that same company’s new AI…
    STAT · 1mo ago↗ source
  • Opinion: How long Covid’s scientific stalemate made it politically erasable
    Long Covid hasn’t disappeared. It’s just gone underground, writes Steven Phillips.
    STAT · 1mo ago↗ source
  • Opinion: How the Amish think about vaccines, health care costs, and much more
    There may be nearly 2 million Amish Americans by 2075. That has large public health implications.
    STAT · 1mo ago↗ source