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  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 3h agoNegative readoutNegative↗ source
  • Novo Nordisk's late-stage anti-inflammatory heart drug fails Phase 3 trial
    Novo Nordisk announced that its experimental anti-inflammatory compound designed to target cardiovascular inflammation did not meet its primary endpoint in a Phase 3 trial. The study was intended…
    Endpoints · 3h agoNegative readoutNegative↗ source
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  • Alnylam cuts TTR franchise guidance, market cap loses $10.8B as shares tumble 28%
    Alnylam announced a reduction in its full-year revenue outlook for its transthyretin (TTR) franchise, trimming the midpoint by $200 million. The company now projects TTR therapy sales of $4.2 bill…
    BioSpace · 6h agoEarningsNegative↗ source
  • Eli Lilly and Resilience commit $750 million to expand U.S. KwikPen device capacity for diabetes and obesity treatments
    Eli Lilly and contract development and manufacturing organization Resilience have announced a $750 million investment to boost U.S. production of the KwikPen device that delivers Lilly’s injectable…
    BioSpace · 2h agoDealPositive↗ source
  • Novo Nordisk's anti-inflammatory drug ziltivekimab fails to cut major heart events in Phase 3 trial
    Novo Nordisk reported that its investigational anti‑inflammatory antibody, ziltivekimab, did not reduce the incidence of major cardiovascular events in a pivotal Phase 3 study. The trial enrolled…
    STAT · 6h agoNegative readoutNegative↗ source
  • AbbVie says Skyrizi maintains strong sales momentum as competition rises
    AbbVie highlighted that its immunology drug Skyrizi continues to generate robust sales despite increasing competition in the market. The company noted that demand for the therapy remains solid and…
    Endpoints · 50m agoPositive↗ source
  • Pharma groups support revised 340B rebate pilot that permits limited rebate denials
    Health Resources and Services Administration (HRSA) announced details of a revised 340B rebate pilot. The new rules would let drug manufacturers refuse rebates on a limited set of drugs, a shift fr…
    Endpoints · 1h agoRegulatoryPositive↗ source
  • AbbVie shares slip 4% as Q2 immunology earnings beat falls short of lofty expectations
    AbbVie’s stock fell about 4% on Friday after the company reported second‑quarter results that modestly exceeded analyst forecasts, disappointing investors who had set very high expectations. The f…
    BioSpace · 3h agoEarningsNegative↗ source
  • Sanofi CEO pledges to rebuild trust and expand partnership with Regeneron
    Sanofi's new chief executive, Belén Garijo, told analysts that restoring the relationship with longtime partner Regeneron is a top priority. She said the company wants to be more transparent and to…
    BioPharma Dive · 4h agoNeutral↗ source
  • Ratio Therapeutics secures $70M Series C for radiopharma trials as Vogenx eyes $67M IPO
    Ratio Therapeutics, a Boston-based biotech, announced a $70 million Series C financing to fund its radiopharmaceutical development program. The round was led by existing backers Duquesne Family Of…
    Endpoints · 4h agoDealPositive↗ source
  • FDA advisory panel backs experimental Replimune melanoma therapy after two prior rejections
    An FDA advisory committee voted 10‑to‑3 to recommend the use of an experimental Replimune treatment for patients with advanced melanoma. The panel’s recommendation marks a shift after the agency p…
    STAT · 5h agoPositive readoutPositive↗ source
  • UniQure prepares for FDA advisory committee on Huntington’s gene therapy amid rare-disease regulatory jitters
    UniQure said it is ready to present its Huntington's disease gene therapy, AMT-130, to an FDA advisory committee, as discussed in its Q2 earnings call. The company expects the FDA may schedule the…
    BioSpace · 6h agoRegulatoryNeutral↗ source
  • Karyopharm stock tumbles after Phase 3 Xpovio trial fails in endometrial cancer
    Karyopharm announced that its Phase 3 XPORT-EC-042 study of Xpovio in endometrial cancer did not meet its primary endpoint. The failure represents the company's second unsuccessful attempt to expa…
    Endpoints · 8h agoNegative readoutNegative↗ source
  • Latigo Biotherapeutics reports non-opioid drug cuts acute pain in Phase 2b trial
    Latigo Biotherapeutics announced that its experimental non-opioid analgesic demonstrated a reduction in acute pain in a Phase 2b clinical trial. The study results suggest the candidate may offer a…
    Endpoints · 11h agoPositive readoutPositive↗ source
  • Trump administration revises 340B rebate pilot, sparking hospital backlash
    The Health Resources and Services Administration announced a revision to the 340B drug pricing program’s rebate pilot, slated to begin on Jan 1, 2027. Under the new rules, participating manufactur…
    STAT · 2h agoRegulatoryNegative↗ source
  • Moderna delays norovirus vaccine readout, cites insufficient infections
    Moderna announced that its norovirus vaccine trial will not yield efficacy data this season because infection rates were lower than expected. The company said it will open an additional trial coho…
    Endpoints · 2h agoNegative readoutNeutral↗ source
  • Apnimed secures $192 million IPO to fund sleep-apnea drug program targeting 2027 launch
    Apnimed, a biotech focused on sleep apnea, announced it raised $192 million through an initial public offering. The capital will be used to advance its lead drug candidate, with plans to begin a l…
    Endpoints · 11h agoDealPositive↗ source
  • Senate advances Erica Schwartz’s CDC director nomination to full Senate vote
    The Senate Health Committee approved Erica Schwartz as the nominee for CDC director, securing bipartisan support that included every Republican member and Democrat Tim Kaine. With the committee’s…
    STAT · 6h agoRegulatoryNeutral↗ source
  • Opinion: Limb girdle muscular dystrophy patients face a maddening reality
    “Too often, regulatory tools authorized to speed patient access to breakthrough treatments are being used in ways that even prevent approval,” writes Kat Bryant Knudson.
    STAT · 10h agoRegulatoryNeutral↗ source
  • Syphilis cases rise among unhoused drug users at San Diego-Tijuana border as researchers face NIH limits and penicillin shortage
    Researchers at the University of California San Diego have been working for years to build trust with unhoused people who use drugs on both sides of the San Diego‑Tijuana border. Their outreach has…
    STAT · 10h agoNegative↗ source
  • ADA’s reputation erodes after controversial physician expulsions at annual meeting
    In a recent opinion piece, Adam Marcus and Ivan Oransky reflect on how their view of the American Diabetes Association (ADA) has shifted. Nine years ago they lauded the organization for defending a…
    STAT · 10h agoNegative↗ source
  • Authors rebut mischaracterization of their 2023 Lancet Covid study in recent op-ed
    The authors of a 2023 Lancet analysis on the United States Covid response wrote to correct a recent First Opinion piece that they say misrepresented their work. While they welcome calls for additio…
    STAT · 10h agoNegative↗ source
  • Bexorg names Bruce Car as new chief scientific officer
    Bexorg announced the appointment of Bruce Car as its chief scientific officer, according to a recent STAT+ column that tracks personnel moves in the pharmaceutical sector. Car joins Bexorg to lead…
    STAT · 4h agoPositive↗ source
  • Ionis veteran scientist Frank Bennett to retire in 2027 as Recursion appoints its first AI chief
    Ionis announced that Frank Bennett, who joined the company as a founding scientist in 1989 and later became chief scientific officer, will retire in February 2027 after a 37-year career. Bennett’s…
    Endpoints · 8h agoNeutral↗ source
  • Capricor CEO won’t rule out legal action against FDA after negative adcomm
    After an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior mot…
    BioSpace · 31m ago↗ source