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24 stories matching this filter · ← front page

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  • B. Braun voluntarily recalls one lot of Excel Lactated Ringers IV solution over particulate contamination
    B. Braun Medical Inc announced a voluntary recall of a specific lot of its Excel Lactated Ringers Injection, a 1000 mL IV solution, after detecting particulate matter in the product. Laboratory an…
    fda recalls · 7h agoCRLNegative↗ source
  • Biokin's EGFR-HER3 bispecific ADC succeeds in late-stage Chinese lung cancer trial
    Chinese biotech Biokin announced that its EGFRxHER3 bispecific antibody-drug conjugate met its primary endpoint in a late-stage trial in a genetically defined subset of non-small cell lung cancer (…
    Endpoints · 17h agoPositive readoutPositive
73
fda recalls47
fda medwatch36
fda press28
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Psychiatry & CNS707
Ophthalmology416
Pain371
Endocrinology & Metabolism370
Infectious Disease346
↗ source
  • 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 · 2d agoPositive readoutPositive↗ 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 · 2d agoApprovalNegative↗ 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 · 2d agoNegative readoutNegative↗ source
  • Taiho and Cullinan's zipalertinib clears Phase 3 trial in EGFR-mutated lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their oral EGFR inhibitor zipalertinib successfully completed a registrational Phase 3 study in patients with a specific genetic form of lung…
    Endpoints · 6d agoPositive readoutPositive↗ source
  • Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
    Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product. The company said the contaminati…
    fda recalls · 10d agoCRLNegative↗ source
  • Merck's anti-TL1A antibody shows benefit in hidradenitis suppurativa but misses endpoint in rare lung disease trial
    Merck reported mixed results from its anti‑TL1A antibody, a product of its $10.8 billion acquisition of Prometheus Biosciences. In a mid‑stage study for hidradenitis suppurativa, the antibody met…
    Endpoints · 15d agoNeutral↗ source
  • Merck to test experimental sac-TMT antibody-drug conjugate with Keytruda in lung cancer trial
    Merck announced it will start a clinical trial testing its experimental antibody-drug conjugate sac-TMT together with the immunotherapy Keytruda in patients with lung cancer. The study will assess…
    Endpoints · 15d agoNeutral↗ source
  • Baxter recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 27d agoCRLNegative↗ source
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 27d agoCRLNegative↗ source
  • FDA approves Nuvalent lung cancer drug shortly after GSK completes $10.6 billion acquisition
    The FDA announced Wednesday that it has approved a lung cancer medicine from Nuvalent, marking a key regulatory milestone for the biotech. The clearance arrived just a week after GlaxoSmithKline c…
    Endpoints · 28d agoApprovalPositive↗ source
  • GSK halts Phase 3 chronic cough drug camlipixant, jeopardizing $2 billion Bellus Health acquisition
    GSK announced it is ending development of camlipixant, a drug aimed at treating refractory chronic cough, after completing Phase 3 trials. The move comes as the company proceeds with its planned $…
    Endpoints · 1mo agoNegative↗ source
  • AstraZeneca to acquire worldwide rights to Dizal's lung cancer drug Zegfrovy for $600 million
    AstraZeneca announced it will pay $600 million upfront to Dizal Pharmaceutical for the worldwide development and sales rights to the lung cancer drug Zegfrovy. The agreement gives AstraZeneca full…
    Endpoints · 1mo agoDealNeutral↗ source
  • Hansoh reports Phase 3 success for GSK‑partnered ADC in SCLC as FDA clears Sanofi on‑body injector
    Hansoh announced that its Phase 3 trial of the antibody‑drug conjugate Ris‑Rez met the primary endpoint in patients with small cell lung cancer. The study was conducted in partnership with GSK and…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • UK regulator advises stopping reimbursement for Amgen's lung cancer drug Lumakras for new patients
    The National Institute for Health and Care Excellence (NICE) in the United Kingdom released draft guidance recommending that government reimbursement for Amgen’s lung cancer therapy Lumakras be dis…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Sino Biopharm hooks AstraZeneca, GSK for separate respiratory partnerships
    Sino Biopharmaceutical announced drug development and sales pacts with two UK pharma companies on Wednesday. One will see the Hong Kong biotech license an investigational PDE3/4 inhibitor to AstraZ…
    Endpoints · 1mo ago↗ source
  • Roche’s KRAS G12C inhibitor beats rivals in head-to-head Phase 3 study
    Roche’s lung cancer drug candidate divarasib has beaten marketed drugs from Amgen and Bristol Myers Squibb in a head-to-head trial. Full data haven't yet emerged, but if the drug's survival benefit…
    Endpoints · 1mo ago↗ source
  • Trodelvy misses in lung cancer, but Gilead and Merck have an HIV success
    Gilead Sciences and Merck have reported a hit and a miss for their Phase 3 HIV and lung cancer programs, respectively, but investors were largely braced for impact, according to Wall Street. The pa…
    Endpoints · 2mo ago↗ source
  • GSK to acquire Nuvalent and its two cancer drugs under FDA review for $10.6B
    GSK is making one of the largest biotech acquisitions in its history to gain access to two experimental lung cancer medicines that are due for FDA approval decisions later this year. The UK drugmak…
    Endpoints · 2mo ago↗ source
  • #ASCO26: Summit, Akeso drug reduces death by 34% in China lung cancer study
    CHICAGO — The leading drug in biopharma's hottest immunotherapy race reduced the risk of death by 34% in previously untreated Chinese lung cancer patients, compared to standard immunotherapy plus c…
    Endpoints · 2mo ago↗ source
  • Acceleron leaders and Westlake jumpstart new IPF biotech
    After success with the drug Winrevair, a band of entrepreneurs has found their next challenge in a difficult-to-treat lung disease. On Tuesday, Oorja Bio launched with a $30 million Series A round,…
    Endpoints · 3mo ago↗ source
  • Full-Life Technologies raises $150M; Quince's reboot with pulmonary drug
    Plus, news about Accro Bioscience, Hansa Biopharma, Shanghai Best-Link Bioscience and UCB. Full-Life Technologies gets $150M: The radiotherapy company has raised $110 million in a Series D round an…
    Endpoints · 3mo ago↗ source
  • Avalyn plots $182M IPO; WHO prequalifies Novartis' malaria drug
    Avalyn Pharma plots $182M IPO: The biotech, which is making inhaled versions of approved pulmonary fibrosis medicines, anticipates about $182 million in net proceeds if it prices its initial public…
    Endpoints · 3mo ago↗ source