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  • FDA approves Bristol Myers' first oral therapy for advanced multiple myeloma, a new drug class
    The U.S. Food and Drug Administration gave its nod to an oral medication from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug represents the first member of a novel clas…
    STAT · 15h agoApprovalPositive↗ source
  • FDA clears Bristol Myers' Zenbexus, first drug of a new class for advanced multiple myeloma
    The FDA announced approval of an oral therapy from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug, iberdomide, will be marketed as Zenbexus and is intended to be used t…
    STAT · 17h agoApprovalPositive↗ source
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  • FDA grants accelerated approval to Bristol's Zenbexus for multiple myeloma; PBMs adopt TrumpRx pricing; Novartis wins UK Entresto patent
    The U.S. Food and Drug Administration granted accelerated approval to Bristol Myers Squibb's oral therapy Zenbexus for patients with advanced multiple myeloma. The drug represents a new class of tr…
    STAT · 13h agoApprovalPositive↗ source
  • Opinion: Car telematics warns of health-insurance data surveillance
    Sociologists Andréa Becker and Paul Kamuf argue that the telematics model used in auto insurance could become a template for health‑insurance data collection. They describe how drivers’ minute‑by‑…
    STAT · 21h agoNegative↗ source
  • Neurocrine’s rare-disease drug approved but later linked to deaths and serious side effects
    Neurocrine Biosciences received regulatory approval for a rare‑disease therapy after a small clinical trial showed modest efficacy and side effects that were considered manageable. The decision was…
    STAT · 1d agoRegulatoryNegative↗ source
  • Oxford study offers model showing statins pose minimal muscle disorder risk, a tool against health misinformation
    The piece highlights how fearmongering about statins has surged online, with claims that the drugs damage the brain, liver and muscles. The authors argue that clearer evidence at the point of claim…
    STAT · 1d agoPositive↗ source
  • FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in China
    The U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product. In Ch…
    raps · 2d agoRegulatoryNeutral↗ source
  • New fertility options give young cancer survivors hope for parenthood
    Young cancer patients are facing increasing concerns about future fertility, prompting the growth of a specialty called oncofertility that blends oncology and reproductive medicine. One patient, J…
    STAT · 1d agoPositive↗ source
  • Patients with treatment-resistant depression weigh pros and cons of brain-implant devices
    A new study surveyed individuals with treatment-resistant depression about their preferences and concerns regarding implantable brain devices aimed at alleviating mood symptoms. Respondents highli…
    STAT · 1d agoNeutral↗ source
  • Study finds cancer patients now wait longer for treatment than a decade ago
    A new analysis of more than 2.7 million cancer cases shows that the interval between diagnosis and the start of therapy has grown over the past ten years. The researchers examined records from a na…
    STAT · 2d agoNegative↗ source
  • WHO and DRC move to fast-track Phase 3 Ebola vaccine trial, starting with Merck’s Ervebo
    The World Health Organization and authorities in the Democratic Republic of the Congo are negotiating to speed up the launch of a multi‑armed Phase 3 trial of Ebola vaccines. The effort targets th…
    STAT · 2d agoCRLPositive↗ source
  • Climate change worsens symptoms for people with chronic illnesses, author reports from Chicago smoke events
    The author argues that climate change is already harming health, particularly for those living with chronic conditions, and that the impact is becoming more evident. She describes a recent summer…
    STAT · 2d agoNegative↗ source
  • Vaping and cannabis use hit record highs among U.S. young adults in 2025, survey finds
    A new national survey by the University of Michigan shows vaping and cannabis use among U.S. young adults reached record levels in 2025. Past‑30‑day nicotine vape use rose to 19%, more than triple…
    STAT · 2d agoNegative↗ source
  • Experts warn splitting MMR vaccine into separate shots could increase missed doses and illness
    The article notes that a recent executive order proposes separating the combined measles, mumps and rubella vaccine into three individual injections. The author argues that this change could lead t…
    STAT · 3d agoRegulatoryNegative↗ source
  • FDA rejects ITM Isotope's radiopharmaceutical therapy over manufacturing problems, halting potential competitor to Novartis
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich SE, citing manufacturing deficiencies. The therapy was desig…
    STAT · 3d agoRegulatoryNegative↗ source
  • Nonprofit North Star Review Board offers independent model to fix IRB oversight issues
    Founders Stephen Rosenfeld and Patricia Seymour created the not‑for‑profit North Star Review Board after becoming disillusioned with the current system of institutional review boards (IRBs) that ov…
    STAT · 3d agoRegulatoryNeutral↗ source
  • MoonLake Immunotherapeutics’ vague data on its autoimmune candidate draws criticism
    Adam Feuerstein notes that MoonLake Immunotherapeutics announced "positive" results for its autoimmune drug candidate but released data that is difficult to interpret. He reminds readers that biot…
    STAT · 3d agoNegative↗ source
  • Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs
    A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 4d agoRegulatoryNeutral↗ source
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 4d agoNegative readoutNegative↗ source
  • FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapy
    The U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent ap…
    STAT · 4d agoRegulatoryNegative↗ source
  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 4d agoNegative readoutNegative↗ source
  • Silence Therapeutics’ divesiran shows 88% response in Phase 2 polycythemia vera trial, challenging Takeda’s upcoming drug
    Silence Therapeutics reported results from a Phase 2 study of its RNA-based therapy divesiran in patients with polycythemia vera, a rare blood cancer that causes excessive red blood cell production…
    STAT · 4d agoPositive readoutPositive↗ source
  • Safety concerns emerge as radiopharmaceuticals advance in cancer trials
    Radiopharmaceuticals are being hailed for their ability to deliver radiation directly to tumours, potentially sparing surrounding healthy tissue and improving cancer therapy. However, as more cand…
    STAT · 4d agoNegative↗ source
  • Replimune secures FDA accelerated approval for melanoma therapy Tudriqev
    Replimune announced that the FDA has granted accelerated approval to its melanoma therapy RP1, marketed as Tudriqev, after two earlier rejections and a third expedited review. The decision reflects…
    STAT · 7d agoApprovalPositive↗ source