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1,294 stories matching this filter · ← front page

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  • AstraZeneca reports positive late-stage results for Tagrisso-Orpathys combo and Enhertu in lung cancer
    AstraZeneca said on Monday that two separate late-stage studies in lung cancer have produced positive outcomes. One study evaluated a combination of the tyrosine-kinase inhibitor Tagrisso with the…
    Endpoints · 5h agoPositive readoutPositive↗ source
  • Eli Lilly signs up to $370 million ion-channel collaboration with OmniAb
    Eli Lilly announced a collaboration and licensing agreement with California-based drug discovery company OmniAb that will focus on ion-channel targets. The deal could see Lilly paying up to $370 m…
    Endpoints · 5h agoDealNeutral↗ source
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Infectious Disease335
  • Drugmakers Back US Probe into Germany’s New Drug Pricing Policies
    Seven major pharmaceutical companies, together with industry groups PhRMA and BIO, have urged the German government to amend its recently introduced drug‑pricing reforms. The coalition voiced supp…
    Endpoints · 2h agoRegulatoryNegative↗ source
  • EyePoint’s Phase 3 eye drug falls short of Eylea, stock tumbles 70%
    EyePoint reported that its experimental treatment for wet age-related macular degeneration did not meet the efficacy endpoints in a Phase 3 trial when compared with the current standard, Eylea. The…
    Endpoints · 4h agoNegative readoutNegative↗ source
  • Biotech raises $820M to bring China-sourced immunology drug to market via reverse merger
    A biotech company has secured $820 million in investor commitments this month to bring its immunology drug, developed in China, to public markets. The funding will be used to complete a reverse me…
    Endpoints · 4h agoDealPositive↗ source
  • Summit and Akeso's ivonescimab wins Chinese first-line lung cancer approval, but longer follow-up shows reduced benefit
    Summit Therapeutics and Akeso announced that their next‑generation PD‑1xVEGF bispecific antibody, ivonescimab, received regulatory approval in China for first‑line treatment of certain lung cancer…
    Endpoints · 5h agoApprovalNegative↗ source
  • Argenx reports Phase 3 success for Vyvgart Hytrulo in autoimmune myositis, despite subgroup shortfall
    Argenx announced that its subcutaneous antibody Vyvgart Hytrulo achieved its primary endpoint in a Phase 3 trial for autoimmune myositis, a rare group of inflammatory muscle diseases. The trial de…
    Endpoints · 9h agoPositive readoutPositive↗ source
  • AstraZeneca halts Phase 3 lung cancer trial of volrustomig after negative results
    AstraZeneca announced on Monday that it is ending the Phase 3 study of its lung-cancer drug volrustomig after the trial failed to meet its primary efficacy endpoints. The company said the data did…
    Endpoints · 9h agoNegative readoutNegative↗ source
  • Eli Lilly signs up to $370M ion-channel collaboration with OmniAb
    Eli Lilly has entered a collaboration with antibody platform company OmniAb that could involve up to $370 million in research, development and commercial milestone payments. OmniAb, which was spun…
    Fierce Biotech · 12h agoDealPositive↗ source
  • AstraZeneca halts phase 3 lung cancer trial of bispecific antibody volrustomig after it falls short of Keytruda
    AstraZeneca stopped its phase 3 trial of the bispecific antibody volrustomig in metastatic non‑small cell lung cancer after interim data suggested the regimen would not meet the study's primary goa…
    Fierce Biotech · 15h agoNegative readoutNegative↗ source
  • FDA clears Lantheus' Tauklarify PET imaging agent for Alzheimer’s tau detection
    Lantheus received FDA clearance for its PET imaging agent Tauklarify, also known as MK-6240, which is designed to help diagnose Alzheimer’s disease by visualizing tau protein deposits. The clearan…
    Fierce Biotech · 12h agoRegulatoryPositive↗ source
  • Regeneron ends eye disease trial for anti-CD3 antibody following safety review
    Regeneron has hit the brakes on the phase 1/2a trial for an experimental eye inflammation treatment, following an adverse event that tilted the drug’s risk/benefit profile in the wrong direction.
    Fierce Biotech · 6h ago↗ source
  • Celcuity awaits FDA review for second factory to launch cancer drug
    Celcuity has provided further details on why the commercial rollout of its recently approved cancer drug is slower than investors initially anticipated. The drugmaker said it is waiting for the FDA…
    Endpoints · 6h ago↗ source
  • Merck KGaA lays off 20 staffers in latest blow to US research team
    The Massachusetts research site for Merck KGaA’s North American division, EMD Serono, has decided to hand pink slips to 20 staffers, Fierce has learned.
    Fierce Biotech · 6h ago↗ source
  • Slate uses Fulcrum to vault onto Nasdaq with $245M financing for migraine trials
    Slate Medicines is hurtling toward a Nasdaq listing, securing a reverse merger with Fulcrum Therapeutics six months after exiting stealth and ahead of the publication of clinical data on its lead c…
    Fierce Biotech · 10h ago↗ source
  • Evaxion scraps solid tumor vaccine to focus on Duke-partnered brain cancer candidate
    Evaxion has scrapped a next-gen solid tumor vaccine in order to channel resources to a candidate specifically targeting brain cancer.
    Fierce Biotech · 10h ago↗ source
  • Baylor Genetics hit by cybersecurity attack targeting patient, staff information
    Diagnostic genomics company Baylor Genetics has become the latest victim of a life sciences cybersecurity breach, with both patients and employees affected.
    Fierce Biotech · 13h ago↗ source
  • Experts propose safety framework for improving predictability, interpretation of CNS toxicity
    The use and implementation of new approach methodologies (NAMs) and digital technologies such as artificial intelligence (AI) may help improve the predictability and interpretation of central nervo…
    raps · 19h ago↗ source
  • Trump orders MMR vaccine as LSD-targeted drug passes Phase 3 trial
    The latest Endpoints Weekly notes that President Trump placed an order for the measles‑mumps‑rubella (MMR) vaccine. The newsletter also reports that a drug being developed for LSD‑related indicati…
    Endpoints · 2d agoPositive readoutNeutral↗ source
  • Biotech firm Biogen secures Chinese approval for felzartamab in second-line multiple myeloma
    Biogen announced that its monoclonal antibody felzartamab has received regulatory clearance in China for use in patients with multiple myeloma who have already received first-line therapy. The app…
    Endpoints · 3d agoApprovalPositive↗ source
  • Skye Bioscience and Redx Pharma combine to form Fibrx Therapeutics with $125M financing for fibrosis pipeline
    Skye Bioscience announced a combination with privately held Redx Pharma, creating a new public company called Fibrx Therapeutics. The transaction is structured as a reverse merger and provides $12…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Capricor plans FDA amendment after advisory committee rejects cardiomyopathy endpoint, stock jumps
    Capricor Therapeutics received a negative vote from an FDA advisory committee on the efficacy of its cell therapy, deramiocel, for treating cardiomyopathy in Duchenne muscular dystrophy. The nine‑t…
    Fierce Biotech · 3d agoRegulatoryPositive↗ source
  • MapLight shifts focus to schizophrenia drug after mixed Phase 2 results, raises $150 million
    MapLight Therapeutics reported mixed outcomes from its Phase 2 Zephyr trial of the muscarinic agonist ML-007C-MA. A twice‑daily dose achieved the study’s primary endpoint with notable reductions in…
    Fierce Biotech · 3d agoDealNeutral↗ source
  • Industry groups urge FDA to add clarity and flexibility to manufacturer-payor communication guidance
    Industry associations and other stakeholders have asked the U.S. Food and Drug Administration to give more detail and flexibility in its updated guidance on how drug and device makers talk with pay…
    raps · 3d agoRegulatoryNeutral↗ source
  • Capricor to submit additional data to FDA after negative advisory committee vote on Duchenne therapy
    Capricor Therapeutics announced it will request the FDA to review new data and analyses for its experimental treatment for Duchenne muscular dystrophy. The move follows a recent negative vote from…
    Endpoints · 3d agoRegulatoryNegative↗ source