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  • Eyepoint’s Phase 3 trial for age‑related blindness treatment fails primary endpoint, jeopardizing approval plans
    Eyepoint announced that its Phase 3 trial of the experimental drug Duravyu for a common cause of age‑related blindness did not meet its primary endpoint. Patients receiving the investigational ther…
    STAT · 27d agoNegative readoutNegative↗ 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 · 27d agoPositive readoutPositive
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  • Academic groups sue DHS over new four-year visa limit for foreign graduate students and postdocs
    Groups representing universities and educators filed a lawsuit in U.S. District Court in Massachusetts against the Department of Homeland Security. The suit challenges a new DHS rule that would re…
    STAT · 26d agoRegulatoryNegative↗ 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 · 26d 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 · 27d agoRegulatoryNegative↗ source
  • FDA releases discussion paper seeking input on regulation of generative AI medical devices
    The U.S. Food and Drug Administration issued a discussion paper outlining considerations for regulating generative AI-enabled medical devices and asked stakeholders to provide feedback. The paper…
    fda press · 27d agoRegulatoryNeutral↗ 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 · 27d 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 · 27d agoPositive readoutPositive↗ source
  • Study shows antibiotic overuse is concentrated in high-income nations, while low-income countries struggle with shortages
    Peter Beyer, deputy executive director of the Global Antibiotic Research & Development Partnership, writes an opinion piece highlighting a shift in how antimicrobial resistance is framed across the…
    STAT · 27d agoNeutral↗ source
  • FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reform
    The U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…
    raps · 27d agoRegulatoryNeutral↗ source
  • Former NIAID adviser David Morens pleads guilty to concealing records and defrauding government
    David Morens, a former top National Institute of Allergy and Infectious Diseases official and longtime senior adviser to former NIAID leader Anthony Fauci, entered a guilty plea on Tuesday on charg…
    STAT · 26d agoRegulatoryNegative↗ source
  • FDA updates guidance to clarify ANDA and 505(b)(2) approval pathways
    The FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways. The guidance clarifies the distinction between traditional Abbreviated New Drug Appl…
    raps · 27d agoRegulatoryNeutral↗ source
  • Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devices
    More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices sugg…
    raps · 27d agoRegulatoryNeutral↗ source
  • White House touts record drug-price drop, but critics say the claim oversimplifies the data
    The administration highlighted a recent Consumer Price Index report showing prescription drug prices fell 3.1% over the 12 months ending in July, the steepest annual decline since 1963, and dropped…
    STAT · 26d agoRegulatoryNegative↗ source
  • Kindergarten vaccine exemptions rise as Doritos marketing sparks food-health debate
    A recent Morning Rounds briefing highlighted that exemptions for childhood vaccines are increasing in kindergarten classrooms, raising concerns among public health observers. The same report also…
    STAT · 27d agoNeutral↗ 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 · 27d agoNegative↗ source
  • Study finds measuring non-clinical influences on FDA approvals is complex
    A new study examined how non-clinical factors might affect the U.S. Food and Drug Administration's drug approval decisions. Researchers concluded that quantifying such influences is challenging be…
    raps · 27d agoRegulatoryNeutral↗ source
  • Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs
    A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.…
    raps · 27d agoRegulatoryNeutral↗ 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 · 26d agoNegative↗ source
  • Dreyer’s Grand Ice Cream voluntarily recalls select Outshine Fruit Bars over possible glass contamination
    Dreyer’s Grand Ice Cream announced a voluntary recall of certain Outshine Fruit Bars after detecting possible foreign material contamination. The recall includes Strawberry, Watermelon, Grape, Tan…
    fda recalls · 26d agoCRLNegative↗ source
  • Bon Secours Mercy Health receives $1.1 billion from Ensemble Health Partners stake in 2026
    Bon Secours Mercy Health, a nonprofit system based in Cincinnati, reported that it has collected more than $1 billion in cash this year from its minority stake in Ensemble Health Partners, a medica…
    STAT · 26d agoDealPositive↗ source
  • L-Nutra recalls Prolon Apulian Almond & Cocoa Spread due to undeclared cashews, pistachios, hazelnuts
    L-Nutra of Culver City, California announced a recall of its Prolon brand Apulian Almond & Cocoa Spread after testing found undeclared tree nut allergens. The affected product is sold in 8.47‑oz (…
    fda recalls · 27d agoRegulatoryNegative↗ source
  • Opinion warns US surrogacy system is chaotic and may face bans after decades of legal battles
    Arthur Caplan writes that the United States surrogacy framework is poorly managed, using the recent West case as a warning sign. He argues that the lack of clear rules could lead to broader bans.…
    STAT · 27d agoNegative↗ source
  • Doritos market themselves as farm-to-table despite being ultra-processed, highlighting industry image push
    Doritos' latest ads portray the nacho cheese snack as a farm-to-table product, showing corn seedlings and a farmer in a PepsiCo hat and claiming a partnership with farmers to bring the chips from f…
    STAT · 27d agoNegative↗ source
  • FDA approves Zenbexus for multiple myeloma as NSAI looks to sell MDR notified body unit
    The U.S. Food and Drug Administration has granted approval for Zenbexus to be used in the treatment of multiple myeloma, marking a new therapeutic option for patients with this blood cancer. The a…
    raps · 28d agoApprovalPositive↗ source