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  • Eli Lilly removes Gaucher disease gene therapy trial from pipeline, citing unmet internal criteria
    Eli Lilly has announced the removal of a phase 1/2 study testing its GBA1 gene therapy for Gaucher disease type 1. The program was part of the assets acquired when the company bought Prevail Therap…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Pathos AI acquires bispecific ADC from Alphamab and secures AstraZeneca partnership
    Pathos AI announced it will pay $125 million upfront for the rights to JSKN016, a bispecific TROP2/HER3 antibody‑drug conjugate from China’s Alphamab Oncology. The agreement also includes up to $2.…
    Fierce Biotech · 1mo agoDealPositive↗ source
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Psychiatry & CNS883
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Endocrinology & Metabolism494
Infectious Disease456
  • Amgen halts development of early-stage obesity drug AMG 513, shifting focus to phase-3 candidate MariTide
    Amgen announced it is stopping work on AMG 513, an early-stage obesity therapy, during its second-quarter earnings call. The decision follows a previous FDA clinical hold in early 2025 that was la…
    Fierce Biotech · 1mo agoNegative↗ source
  • Expedition Therapeutics raises $115M Series B to fund phase 2 COPD trial of DPP1 inhibitor
    Expedition Therapeutics, backed by Sanofi, announced a $115 million Series B financing round. The round was led by General Atlantic with participation from RA Capital, Vivo Capital, and existing i…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Lisata cuts 72% of workforce and sues Kuva after merger collapse
    Lisata, a solid tumor biotech, announced it is laying off roughly 72% of its employees, including its chief medical officer, as it reassesses its future. The cuts follow the collapse of a planned…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source
  • Merck’s anti‑TL1A antibody misses SSc‑ILD trial but hits primary endpoints in hidradenitis suppurativa
    Merck's anti‑TL1A monoclonal antibody, tulisokibart, was evaluated in two phase 2 studies. In the systemic sclerosis‑associated interstitial lung disease (SSc‑ILD) trial, the primary endpoint was…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Icon partners with Anthropic to integrate Claude AI into clinical trial planning
    Icon, a contract research organization, announced a multi-year collaboration with Anthropic to bring the Claude AI system into its clinical trial operations. The partnership will combine Anthropic…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Smith & Nephew lowers 2026 sales outlook as US knee implant revenue falls 7%
    Smith & Nephew announced a revision to its 2026 sales outlook, now expecting underlying revenue growth of about 4% versus the prior 6% target. The change follows a second‑quarter report showing re…
    Fierce Biotech · 1mo agoEarningsNegative↗ source
  • Pfizer drops two obesity programs, including Metsera-derived GLP-1 candidate, in pipeline cleanout
    Pfizer announced it is removing two clinical‑stage obesity programs as part of its quarterly pipeline cleanout. The first program, MET-224o, is an oral ultra‑long‑acting GLP‑1 receptor agonist tha…
    Fierce Biotech · 1mo agoNegative↗ source
  • KKR to acquire medtech maker Integer in $5.7 billion deal
    KKR announced an agreement to take Integer private for approximately $5.7 billion, offering $127 per share in cash to Integer stockholders. Integer, based in Plano, Texas, saw its shares rise abou…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Latigo Biotherapeutics targets non-opioid pain market with $247 M IPO
    Latigo Biotherapeutics announced details of its planned initial public offering, aiming to raise roughly $247 million to advance its pipeline of non-opioid pain treatments. The company intends to…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Early Alert: Intraosseous Needle Set Issue from Becton Dickinson
    BD is recalling certain BD Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator (stylet) following placement.
    fda medwatch · 1mo agoRegulatoryNeutral↗ source
  • Lilly expands access to its experimental obesity therapy while Jazz pulls Zepzelca's second-line lung cancer use
    Lilly announced it will broaden the expanded‑access program for its obesity drug that has not yet received regulatory approval, allowing more patients to receive the treatment under a compassionate…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA invites stakeholder input to shape a new Quantitative Medicine Innovation Network
    The FDA announced it is looking for feedback from a broad range of stakeholders to help design a Quantitative Medicine Innovation Network (QMIN). The proposed QMIN would be a cross-sector platform…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Liebel-Flarsheim recalls OPTIRAY imaging contrast agent after detecting plastic, metal and glass particles
    Liebel-Flarsheim Company announced a recall of one lot of its OPTIRAY Imaging Bulk Package, a 350/500 mL vial of ioversol injection used for intra‑arterial and intravenous imaging. The recall was…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Experts debate extra regulation for low-risk digital wellness devices
    Two recent papers published in JAMA have highlighted concerns about low-risk digital health technologies that consumers use. Experts say that even though these tools are considered low-risk, they…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Curium to acquire Lantheus in deal valued up to $8 billion
    Curium announced it will purchase all outstanding shares of Lantheus for $102.50 cash per share, with potential additional $12 per share via contingent value rights linked to sales milestones in pr…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Analyst warns AstraZeneca-BMS merger could spark regulatory hurdles and job cuts
    Angus Liu writes an editorial warning that talks of a merger between AstraZeneca and Bristol Myers Squibb could create more problems than benefits. He notes that the two companies have only discuss…
    Fierce Biotech · 1mo agoDealNegative↗ source
  • BlossomHill Therapeutics targets $112 million IPO to fund EGFR lung-cancer drug BH-30643
    BlossomHill Therapeutics, a San Diego oncology biotech, announced plans for an initial public offering to raise about $112 million. The company intends to sell 7.8 million shares at $15-$17 each,…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • BD recalls specific lots of intraosseous needle sets over obturator removal issues
    BD announced a voluntary recall of certain lots of its intraosseous vascular access system needle sets after users reported difficulty removing the obturator after placement. The issue is linked t…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Medical Action Industries issues correction for convenience kits with recalled Namic manifolds
    Medical Action Industries has issued a correction notice for certain convenience kits that contain Namic manifolds previously recalled by Medline. The company advises customers to immediately chec…
    fda medwatch · 1mo agoCRLNegative↗ source
  • TGA seeks industry input on adopting 11 international scientific guidelines in Australia
    The Therapeutic Goods Administration announced it will consider incorporating eleven internationally recognised scientific guidelines into the Australian regulatory framework. The agency has opene…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Medline orders correction of convenience kits containing lidocaine and bupivacaine in dextrose injection
    Medline has issued a correction for certain convenience kits that include lidocaine hydrochloride and bupivacaine hydrochloride mixed with dextrose injection. The FDA has classified this recall as…
    fda medwatch · 1mo agoCRLNegative↗ source