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  • Scancell plans Neuphoria merger; AstraZeneca wins EU nod for cancer drug
    Scancell to merge into Neuphoria: Scancell plans to take over Neuphoria Therapeutics' Nasdaq listing {$NEUP} and change the ticker to SCLT. The company eyes up to $89 million in equity and ...
    Endpoints · 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
  • 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.
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STAT · 1d ago
↗ source
  • Biogen counts on drugs from Apellis deal to patch Leqembi's slow sales
    It’s no secret that sales of Leqembi have been disappointing. First approved in 2023, the Alzheimer’s drug from Eisai and Biogen launched shortly after Chris Viehbacher took the reins as Biogen C…
    Endpoints · 1d ago↗ source
  • What’s behind the proposed pullback on remote patient monitoring
    Companies that help doctors keep tabs on their patients at home are freaking out after Medicare's proposal last week to gut remote patient monitoring, or RPM. The plan is a total about-face from…
    Endpoints · 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
  • Repligen’s $1.5B buy for BioLife; BeOne’s $300M US expansion
    Plus, news about Lonza, Bachem and Samsung Biologics. 🤝 Repligen to acquire BioLife Solutions: Repligen will pay around $1.5 billion for cell processing service supplier BioLife, 36% of which w…
    Endpoints · 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
  • 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
  • Lilly's triple agonist heads to regulators after two more Phase 3 obesity wins
    Retatrutide, the obesity candidate that has shown the most powerful weight loss in late-stage trials, will be filed for approval early next year, its developer Eli Lilly said Thursday. The filing…
    Endpoints · 1d ago↗ source
  • Roche says it is thoughtful on token use for AI, shelves a drug from Carmot buy
    Roche has offered some insight into how it is using AI, from drug discovery to token use. AI has already contributed to “a significant increase in new molecules” in its pipeline, CEO Thomas Schin…
    Endpoints · 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
  • Exclusive: Obesity biotech Verdiva hires ex-Metsera CMO as crucial readouts near
    Long-acting obesity pill developer Verdiva Bio has a new chief medical officer, and he comes from a biotech that was looking at very similar technology — and got bought for $10 billion not long ago…
    Endpoints · 1d ago↗ source
  • Teladoc is moving beyond its single-visit roots with new launch
    Over two decades ago, Teladoc built its business around quick doctor visits that didn't happen in person. Now, it's saying that the model of one-off virtual appointments is no longer enough. The…
    Endpoints · 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
  • Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 1d ago↗ source
  • Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies
    <p>The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.</p>
    raps · 1d ago↗ source
  • Study: Most sponsors complete postmarketing trials, publish results
    <p>Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the…
    raps · 1d ago↗ source
  • FDA advisory committee backs two controversial peptides
    <p>An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for woun…
    raps · 1d ago↗ source