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3,226 stories matching this filter · ← front page

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  • FDA asks industry input on competency-based rules for generative AI medical devices
    The FDA announced it is soliciting comments on a proposed competency-based framework for overseeing medical devices that incorporate generative artificial intelligence. The agency says the approac…
    raps · 15d agoRegulatoryNeutral↗ source
  • Cellares to cut 100 jobs after losing contract with unnamed large pharma customer
    Cellares, a cell therapy manufacturing startup based in South San Francisco, announced it will lay off about 100 employees. The cuts follow the termination of a contract by an unnamed large pharma…
    BioPharma Dive · 14d agoLayoffsNegative↗ source
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  • FDA pushes back PDUFA date for Capricor's Duchenne therapy to review new data
    The U.S. Food and Drug Administration announced it has extended the PDUFA target date for Capricor Therapeutics' investigational Duchenne muscular dystrophy treatment. The agency said the extensio…
    Endpoints · 14d agoRegulatoryNegative↗ source
  • Medicaid coverage for GLP-1 weight-loss drugs stalls, only Indiana signs on
    President Trump pledged to broaden Medicaid access to costly GLP-1 obesity medications by letting states negotiate prices directly with manufacturers. The rollout depended on state participation,…
    STAT · 14d agoRegulatoryNegative↗ source
  • FDA signals upcoming rules for generative AI use in drug development
    The FDA announced it intends to create regulatory guidance for the use of generative artificial intelligence in pharmaceutical research and development. The move follows growing interest in AI too…
    STAT · 14d agoRegulatoryNeutral↗ source
  • FDA finalizes guidance on therapeutic equivalence evaluations for ANDAs
    The U.S. Food and Drug Administration has issued final guidance describing its approach to therapeutic equivalence (TE) evaluations and the assignment of TE codes for abbreviated new drug applicati…
    raps · 15d agoRegulatoryNeutral↗ source
  • Bausch + Lomb to launch Phase 3 trial of dry‑eye drop after Phase 2 miss
    Bausch + Lomb announced plans to move its dual‑action dry‑eye drop into a Phase 3 study. The decision follows a Phase 2 trial that did not meet its primary endpoint. CEO Brent Saunders said the r…
    Endpoints · 14d agoNegative readoutNeutral↗ source
  • Cardio firms including AstraZeneca and Novartis to showcase heart drug data at ESC 2026
    At the European Society of Cardiology's annual meeting in 2026, several pharmaceutical companies will present cardiovascular data. The lineup includes AstraZeneca, Ionis, Cytokinetics, Novartis an…
    Endpoints · 14d agoNeutral↗ source
  • Aon warns 2027 will bring steep rise in employer health premiums, highlighting data gaps for public-sector plans
    Aon’s chief actuary warned that 2026 data points to a harsh 2027 for employer-sponsored health insurance premiums, with costs expected to rise sharply. The firm said employers will need better dat…
    STAT · 14d agoNegative↗ source
  • Health Secretary Kennedy criticizes CDC vaccine classification scheme and shared decision-making category
    Robert F. Kennedy Jr., serving as Health Secretary, has raised concerns about how the CDC categorizes vaccine recommendations. The CDC uses three categories: routine recommendations for universal…
    BioSpace · 14d agoRegulatoryNegative↗ source
  • Australian regulator TGA opens consultation on automated decision making for listed medicine variations
    The Therapeutic Goods Administration has launched a public consultation to gather input on proposed changes that would enable automated decision making for variation applications of listed medicine…
    raps · 15d agoRegulatoryNeutral↗ source
  • Boehringer Ingelheim pauses Phase 1 study of oral candidate BI 3031185 after safety event
    Boehringer Ingelheim has placed a Phase 1 study of its oral candidate BI 3031185 on hold after a safety event was identified. The trial, run in Japan with healthy volunteers, was assessing tolerab…
    BioSpace · 14d agoCRLNegative↗ source
  • Study finds SNAP soda bans cut purchases by 12% among beneficiaries
    A new study shows that purchases of soda fell by roughly 12% among people receiving Supplemental Nutrition Assistance Program benefits after the bans on soda and candy took effect in ten states. Th…
    STAT · 15d agoRegulatoryPositive↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 14d agoNeutral↗ source
  • Handshakes in the ER: A simple gesture can ease patient anxiety
    An emergency medicine resident at Northwestern University recounts a recent shift where a patient faced a suspected oncologic emergency. The physician introduced herself with a handshake to the pat…
    STAT · 15d agoPositive↗ source
  • Nurse practitioner students struggle to find clinical preceptors, often paying thousands
    Nurse practitioner graduate programs require students to complete at least 500 hours of supervised patient care with a licensed preceptor. Across the United States, a shortage of qualified precepto…
    STAT · 15d agoNegative↗ source
  • Retired cardiologist finds new purpose volunteering at Maryland community clinic, highlights gaps in US health care
    A cardiologist who spent nearly four decades in private practice retired in 2022 and soon after began volunteering at a nonprofit community clinic in Maryland. The clinic serves the "working poor"…
    STAT · 15d agoNeutral↗ source
  • Texas lawmaker warns Chinese biotech firms gaining early-stage advantage over U.S. industry
    Rep. Nathaniel Moran, a Republican from Texas and member of the House Select Committee on China, told Fierce that the United States is overlooking how Chinese biotech companies are outpacing Americ…
    Fierce Biotech · 15d agoNeutral↗ source
  • Merck and Moderna report positive topline results for personalized cancer vaccine
    A third death was reported in China’s expedited clinical trials, raising safety concerns for fast‑track studies in the region. Merck and Moderna announced positive topline data from their personal…
    Endpoints · 17d agoPositive readoutPositive↗ source
  • Lilly leads GLP-1 weight-loss market while Novo Nordisk’s Wegovy exceeds expectations but falls short of forecasts
    Eli Lilly and Novo Nordisk are intensifying their battle for dominance in the multibillion‑dollar GLP‑1 weight‑loss market, with each company promoting its own set of injectable therapies and pipel…
    BioPharma Dive · 17d agoEarningsNeutral↗ source
  • Cure for HIV must protect long-term survivors from loss of benefits
    The authors, a postdoctoral researcher, a long‑term HIV survivor, and the head of a survivor alliance, argue that a future HIV cure should not jeopardize the support systems that have kept many pat…
    STAT · 18d agoNeutral↗ source
  • US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deaths
    Three recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…
    BioSpace · 17d agoRegulatoryNegative↗ source
  • Roche's Genentech to invest $750 million to double Oregon manufacturing site
    Roche's Genentech announced a $750 million investment to expand its existing production facility in Oregon, with the goal of doubling its capacity. The expanded site is expected to boost manufactu…
    STAT · 17d agoDealNeutral↗ source
  • Takeda wins FDA nod for orexin drug oveporexton, first treatment for narcolepsy type 1 and potential broader uses
    Takeda received FDA approval for oveporexton (brand Orzeyful), an orexin receptor agonist, marking the first approved therapy that targets the orexin system for narcolepsy type 1. The drug mimics…
    Fierce Biotech · 17d agoApprovalPositive↗ source
  • HHS seeks public input on new vaccine recommendation categories under Trump and Kennedy
    A request for information was posted by the Department of Health and Human Services, giving the public a 30‑day window to comment on potential changes to the U.S. vaccine recommendation framework.…
    STAT · 17d agoRegulatoryNeutral↗ source