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1,539 stories matching this filter · ← front page

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  • Experts: Ending adequate provision would shut down prescription drug ads
    The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the hig…
    raps · 28d ago↗ source
  • Industry wants more clarity on NGS for assessing gene therapy safety
    The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products. Ho…
    raps · 28d ago↗ source
  • This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This wee…
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fda press25
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Infectious Disease321
raps · 28d ago↗ source
  • STAT+: Fresh turmoil roils American Diabetes Association following controversy at conference
    Turmoil at the ADA has taken a fresh turn, with leaders blocking editors at its flagship journal from publishing pieces detailing a controversy at the group’s annual meeting.
    STAT · 28d ago↗ source
  • Predicting biotech clinical trials and a new Alzheimer’s drug controversy
    This week on "The Readout LOUD" podcast: a new Alzheimer's drug controversy and prediction markets for clinical trials and FDA drug reviews. Listen now.
    STAT · 28d ago↗ source
  • STAT+: GOP blocks effort to end Medicare test of AI prior authorization
    The Trump administration is testing the use of AI in Medicare to approve some medical services.
    STAT · 28d ago↗ source
  • STAT+: Despite earnings celebration, UnitedHealth signals more financial pain for employers
    Insurance giant UnitedHealth signals the cost of providing workers with health insurance will climb even higher.
    STAT · 28d 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 · 28d ago↗ source
  • WHO: Uganda is silent on updates following disclosure of Marburg outbreak
    The government of Uganda has gone quiet on an outbreak of the deadly Marburg virus that it reported late last month, the WHO acknowledged.
    STAT · 28d ago↗ source
  • Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics
    The latest in a prolific streak of buyouts by Lilly is the strongest sign yet that large pharmaceutical companies may finally be embracing a long-dismissed field of research.
    BioPharma Dive · 28d ago↗ source
  • Veradermics keeps ‘momentum going’ as baldness drug helps women with hair loss
    The Phase 2 data exceeded expectations, lifting company shares as high as nearly $130 apiece and building the case for what may be the first pill specifically approved for female pattern hair loss.
    BioPharma Dive · 28d ago↗ source
  • STAT+: Brain implant restores the sensation of touch in a person with quadriplegia
    A brain-computer interface helped restore movement and sensation in a 48-year old man with quadriplegia, researchers say.
    STAT · 28d ago↗ source
  • STAT+: Medicare wants to shake up how it pays for clinical AI
    In this edition of STAT Health Tech: Centers for Medicare and Medicaid Services proposes major changes to RPM, clinical AI payment models.
    STAT · 28d ago↗ source
  • Merck wins first approval of a PCSK9 cholesterol pill
    The speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in place by former FDA commissioner Marty Makary.
    BioPharma Dive · 28d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Kalshi bets on clinical trials, a Merck cholesterol pill, and more
    Kalshi, one of the world’s largest prediction market exchanges, plans to take bets on clinical trials and regulatory approvals
    STAT · 28d ago↗ source
  • STAT+: FDA approves Merck’s oral PCSK9 drug, a first
    Kalshi allows bets on clinical trial outcomes, Eli Lilly buys a psychedelic medicine, and more biotech news from The Readout
    STAT · 28d ago↗ source
  • STAT+: Kalshi comes for biopharma, with prediction markets for clinical trials and FDA approvals
    Prediction markets have permeated the worlds of sports, politics, and reality television shows. Now, the biopharma industry could be next.
    STAT · 28d ago↗ source
  • STAT+: Eli Lilly to acquire psychedelics-focused biotech AtaiBeckley
    Eli Lilly is buying the psychedelics-focused biotech AtaiBeckley for $2.8 billion upfront, a move that will expand its neuroscience pipeline.
    STAT · 28d ago↗ source
  • STAT+: Spring forward forever? Another daylight saving debate arrives in Congress
    Trump's pandemic preparedness nominee testifies, the "fang-to-pharmacy" pipeline, and more health news from Morning Rounds
    STAT · 28d ago↗ source
  • STAT+: Amylyx nears pivotal endocrine drug study readout
    Amylyx Pharmaceuticals will soon read out results from a study evaluating a new treatment for a rare endocrine disorder, a pivotal moment for patients and the company.
    STAT · 28d ago↗ source
  • Opinion: The growing fang-to-pharmacy pipeline
    “Some of the most powerful medicines we will ever find are already here, carried in the fangs, stingers, and saliva of creatures we’ve been taught to fear,” writes Steve Midway.
    STAT · 29d ago↗ source
  • Opinion: Medicaid and SNAP cuts are exacerbating the intertwined problems of hunger and mental illness
    “No one built a psychiatric unit to solve hunger,” writes clinical dietician Cole Hanson. But patients come anyway.
    STAT · 29d ago↗ source
  • STAT+: CMS signals intent to revamp how it pays for clinical software and AI
    CMS wants to build a standardized payment structure for clinical software and AI that factors in their impact on patient outcomes.
    STAT · 29d ago↗ source
  • Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 29d ago↗ source
  • Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile products
    The European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.
    raps · 29d ago↗ source