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247 stories matching this filter · ← front page

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  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 7h agoPositive readoutPositive↗ source
  • Moderna's cancer vaccine boost lifts stock, sparks talk of Keytruda-like reach
    Moderna’s shares surged 177% after a phase 3 topline win for its Merck‑partnered cancer vaccine, intismeran autogene, was disclosed. The data, released on Wednesday, added roughly $45 billion to Mo…
    Fierce Biotech · 13h agoPositive readoutPositive↗ source
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fda recalls47
fda medwatch38
fda press28
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Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism382
Pain376
Infectious Disease356
  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
  • AstraZeneca’s Tagrisso plus Orpathys improves survival in MET-mutated lung cancer
    A new combination therapy using AstraZeneca’s Tagrisso together with Hutchmed’s Orpathys has shown a survival benefit for patients with a specific form of non‑small cell lung cancer. The study focu…
    BioPharma Dive · 2d agoPositive readoutPositive↗ source
  • Amylyx avexitide cuts serious low blood sugar events by 55% in Phase 3 trial for post bariatric hypoglycemia
    Amylyx Pharmaceuticals reported that its experimental drug avexitide significantly reduced the frequency of serious low blood sugar episodes in a Phase 3 study of patients with post‑bariatric hypog…
    STAT · 2d agoPositive readoutPositive↗ source
  • J&J MedTech secures FDA 510(k) clearance for Monarch Quest 3 bronchoscopy software update
    Johnson & Johnson MedTech announced that its Monarch bronchoscopy robot has received FDA 510(k) clearance for the latest software version, Monarch Quest 3. This marks the fourth major software laun…
    Fierce Biotech · 2d agoRegulatoryPositive↗ source
  • Amylyx reports positive pivotal trial results for drug targeting post-bariatric hypoglycemia
    Amylyx announced that its experimental therapy achieved statistically significant improvement in patients who experience severe hypoglycemia after bariatric surgery. The company said the pivotal t…
    STAT · 2d agoPositive readoutPositive↗ source
  • Municipalities and States Grapple with Rising Health-Insurance Costs and Upcoming Medicaid Drug Pricing Deadline
    Municipalities across the country are reporting that the cost of providing health insurance to their employees is becoming increasingly unsustainable, putting pressure on local budgets. States are…
    STAT · 2d agoRegulatoryNegative↗ source
  • GenBio AI launches AIDO Cell, a virtual model that simulates whole-cell behavior
    GenBio AI, a Palo Alto startup, unveiled AIDO Cell, a virtual cell platform that lets researchers view a cell’s interior like a map. The system visualizes proteins, RNA and DNA and can simulate gen…
    STAT · 2d agoPositive↗ source
  • Enveda reports promising Phase 1 data for oral drug that mimics exercise to preserve muscle during weight loss
    Enveda, a biotech based in Boulder, Colorado, announced Phase 1 results for its oral candidate ENV-308, a chemically engineered version of the metabolite lactate phenylalanine (lac-phe). The metabo…
    STAT · 2d agoPositive readoutPositive↗ source
  • Rising health-care costs force Pennsylvania county to raise property taxes by 22%
    Bob Herman interviewed state and local officials, health policy experts, and industry executives about the growing burden of health‑care expenses for government workers. The investigation found tha…
    STAT · 2d agoNegative↗ source
  • Mass General and Dana-Farber CEOs receive record compensation in 2024 amid hospital cost pressures
    Newly released compensation records show that chief executives of major Massachusetts health systems earned substantially higher pay in 2024. Dr. Anne Klibanski, the CEO of Mass General Brigham, t…
    STAT · 2d agoNegative↗ source
  • Eyepoint's wet AMD therapy misses primary goal in Phase 3, stock tumbles
    Eyepoint reported that its experimental drug Duravyu did not keep vision in patients with wet age-related macular degeneration when given less frequently than the standard of care, causing the Phas…
    STAT · 3d agoNegative readoutNegative↗ source
  • AstraZeneca halts Phase 3 lung cancer trial of bispecific antibody volrustomig after interim data miss survival goal
    AstraZeneca announced termination of the Phase 3 study of its experimental bispecific antibody volrustomig in non‑small cell lung cancer. An interim data review by trial monitors indicated the dru…
    BioPharma Dive · 3d agoNegative readoutNegative↗ source
  • Chinese biotech CEOs say US tensions won’t curb booming licensing deals
    Chinese biotech CEOs say they are not worried about rising US political tension and regulatory scrutiny. US lawmakers have increased scrutiny, referencing the America First Investment Policy and t…
    Fierce Biotech · 3d agoNeutral↗ source
  • Sanofi to cut 229 Massachusetts jobs a year after $9.1 billion Blueprint Medicines acquisition
    Sanofi announced it will lay off 229 employees in Massachusetts, according to a filing with the state's Executive Office of Labor and Workforce Development. The workers are from Blueprint Medicine…
    STAT · 3d agoLayoffsNegative↗ source
  • IRS probes UnitedHealth tax filings and private-equity deals for doctor groups slow down
    UnitedHealth disclosed that the IRS has opened an investigation into its tax filings for 2017-2020, seeking to increase the company’s taxable income and potentially raise its tax bill for those yea…
    STAT · 3d agoRegulatoryNegative↗ source
  • Akeso and Summit’s lung cancer candidate shows worsening tumor progression, while Europe halts Tavneos over trial concerns
    Akeso Therapeutics and Summit Therapeutics reported that their combined lung cancer therapy failed to improve outcomes, with data indicating a worsening in tumor progression compared to control. T…
    STAT · 3d agoNegative readoutNegative↗ source
  • AstraZeneca halts late-stage trial of volrustomig in metastatic lung cancer
    AstraZeneca said it is stopping a late-stage study of its experimental drug volrustomig combined with chemotherapy in patients with metastatic non-small cell lung cancer. The company made the decis…
    STAT · 3d agoNegative↗ source
  • AstraZeneca halts phase 3 lung cancer trial of bispecific antibody volrustomig after it falls short of Keytruda
    AstraZeneca stopped its phase 3 trial of the bispecific antibody volrustomig in metastatic non‑small cell lung cancer after interim data suggested the regimen would not meet the study's primary goa…
    Fierce Biotech · 3d agoNegative readoutNegative↗ source
  • Evaxion drops solid tumor vaccine program to prioritize brain cancer vaccine candidate
    Evaxion Biotech announced it has discontinued development of its next‑generation solid tumor vaccine, EVX‑03, and will redirect resources toward a brain cancer vaccine candidate developed with Duke…
    Fierce Biotech · 3d agoNeutral↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 6d agoRegulatoryPositive↗ source
  • Two undisclosed gene-therapy deaths raise doubts about China's fast-track trial pathway
    Two recent deaths in China’s early‑stage gene‑therapy trials have drawn international attention. Both patients suffered severe immune reactions after receiving high‑dose viral vector treatments, an…
    Fierce Biotech · 6d agoRegulatoryNegative↗ source
  • Skye Bioscience and Redx Pharma combine to form Fibrx Therapeutics with $125M financing for fibrosis pipeline
    Skye Bioscience announced a combination with privately held Redx Pharma, creating a new public company called Fibrx Therapeutics. The transaction is structured as a reverse merger and provides $12…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Taiho and Cullinan report positive Phase 3 results for zipalertinib in EGFR exon 20 insertion lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their experimental drug zipalertinib achieved positive results in a Phase 3 trial for first‑line treatment of lung cancer patients whose tumo…
    BioPharma Dive · 7d agoPositive readoutPositive↗ source