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  • STAT+: European regulators take steps to bolster clinical trial transparency
    The European Medicines Agency is taking what advocacy groups are calling unexpectedly “rapid action” to ensure that clinical trial results are made public as required by law.
    STAT · 1d ago↗ source
  • STAT+: Popular insulin product enters shortage as other pens leave market
    The Lantus Solostar insulin pen isn't in official FDA shortage, but patients are having a tough time finding it.
    STAT · 1d ago↗ source
  • Senate health panel delays vote on CDC nominee
    Too few senators were in attendance to proceed with a vote on the CDC director nominee.
    STAT · 1d ago↗ source
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  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    <figure><div><img src="https://imgproxy.divecdn.com/x5fF_ZCHHBjPFAGFuuKXSVkAgBGYTo2hZBIz9OcQdEo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMDkyNDczMjEzLmpwZ…
    BioPharma Dive · 1d ago↗ source
  • STAT+: What’s in the last-minute flurry of health care bills?
    Congress is scrambling to advance a slew of health care bills before an August recess. Price transparency and prior authorization top the list.
    STAT · 1d ago↗ source
  • FDA panel confronting peptide controversy
    Today's biotech news features the FDA weighing the fate of peptides; approvals for RevMed, GSK; and data on Lilly's "triple-G."
    STAT · 1d ago↗ source
  • A father’s mission to save his daughter, and allegations on telehealth GLP-1 prescribing
    Has a wanted fugitive been posing as a biotech executive? And what does it take to develop a therapy for an ultra-rare disease? Find out on this week's episode of…
    STAT · 1d ago↗ source
  • CLINUVEL will cut up to 20% of staff, relocate HQ to New York
    Follow along as BioSpace tracks job cuts and restructuring initiatives.
    BioSpace · 1d ago↗ source
  • BeOne commits $300M to US manufacturing expansion, creating 120 new jobs
    The addition of small molecule capacity at BeOne Medicines’ Hopewell site will support the company’s hematology efforts and bring total investment in the campus to more than $1 billion.
    BioSpace · 1d ago↗ source
  • STAT+: Vote on key federal health nominee delayed amid questions over vaccine views
    Sean Kaufman, nominated to run ASPR, has a track record of questioning the safety of vaccines.
    STAT · 1d ago↗ source
  • STAT+: Trump administration quietly picks Timothy Westlake to lead mental health agency
    Timothy Westlake, an emergency doctor nominated to head SAMHSA, has been active in addiction policy in Wisconsin.
    STAT · 1d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Lilly obesity drug data, a push for FDA to ban DTC ads, and more
    A study of Lilly's retatrutide weight loss drug in people with heart disease did not answer a crucial question — whether it reduces cardiovascular risk
    STAT · 1d ago↗ source
  • STAT+: HHS to convene experts on standards for clinical AI
    In this edition of STAT Health Tech: HHS is inviting experts to shape policy on clinical AI, Whoop's new CMO, news about brain implants, and more.
    STAT · 1d ago↗ source
  • STAT+: FDA is urged by advocacy group to ban DTC prescription drug ads
    A leading advocacy group petitioned the FDA to ban direct-to-consumer advertising of prescription medicines.
    STAT · 1d ago↗ source
  • Lilly preps FDA run for ‘triple-G’ weight loss drug with Phase 3 data
    With weight loss topping 20% at 80 weeks in the Phase 3 TRIUMPH-2 and TRIUMPH-3 trials, Eli Lilly plans to file for retatrutide’s approval in the first quarter of 2027. Previously a filing was expe…
    BioSpace · 1d ago↗ source
  • Roche's late stage pipeline 'so full,' CEO Schinecker not feeling pressure to add on
    Roche has 19 investigational medicines that could launch by 2030—and even if not all of them make it to market, the company is “well set-up for growth into the next decade,” CEO Thomas Schinecker s…
    BioSpace · 1d ago↗ source
  • GSK’s $10.6B Nuvalent bet pays off early as FDA approves lung cancer drug
    Jideytro is GSK’s first approved product for lung cancer. With its takeover of Nuvalent Bio last month and a deal with Hansoh Pharmaceutical in 2023, the pharma now has several other lung cancer as…
    BioSpace · 1d ago↗ source
  • Expect a clash at today’s FDA peptide panel
    The service members who refused the Covid vaccine, the fastest-growing Ebola outbreak in history, and other health news from Morning Rounds
    STAT · 1d ago↗ source
  • STAT+: New data on Eli Lilly’s ‘triple-G’ drug leave open questions on heart benefit
    On analyses that looked at major cardiovascular events, those taking retatrutide did not have a significant lower risk of death, heart attack, or stroke.
    STAT · 1d ago↗ source
  • Nordic biotech’s next act: From fragmentation to global force
    In this episode of Denatured, you’ll hear from Ester Sklarsky, principal at Sound Bioventures and João Ribas, partner at Novo Holdings Seed Investments. In this episode, we explore the diverging tr…
    BioSpace · 1d ago↗ source
  • Filing of bipartisan Senate bill boosts momentum for office of men’s health
    Mirroring the bipartisan bill introduced in the House, the measure would require a study from the GAO on the state of men’s health in the U.S. to be presented within…
    STAT · 1d ago↗ source
  • STAT+: Trump promised redemption for troops who refused Covid shots. A year later, many are still waiting
    Veterans who want to rejoin the military are often bogged down in bureaucratic red tape.
    STAT · 1d ago↗ source
  • Opinion: New billing codes likely to raise maternity care costs
    “This change is likely to lead to only modest increases in total medical expenses. However, it coincides with many other factors raising health insurance premiums,” writes Jeff Levin-Scherz.
    STAT · 1d ago↗ source
  • Opinion: Good riddance to bundled ‘global’ maternal care billing
    New maternal billing codes should create a transparent system where both patients and clinicians can thrive, ACOG writes.
    STAT · 1d ago↗ source
  • STAT+: FDA staff and peptide enthusiasts set to clash at advisory panel
    FDA advisers are set to consider whether allowing compounding pharmacies to offer largely unproven peptides is a safer bet than the gray-market versions now in use.
    STAT · 1d ago↗ source