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116 stories matching this filter · ← front page

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  • Moderna's cancer vaccine boost lifts stock, sparks talk of Keytruda-like reach
    Moderna’s shares surged 177% after a phase 3 topline win for its Merck‑partnered cancer vaccine, intismeran autogene, was disclosed. The data, released on Wednesday, added roughly $45 billion to Mo…
    Fierce Biotech · 13h agoPositive readoutPositive↗ 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 · 1d agoPositive readoutPositive↗ source
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fda medwatch38
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Psychiatry & CNS712
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Endocrinology & Metabolism382
Pain376
Infectious Disease356
  • J&J MedTech secures FDA 510(k) clearance for Monarch Quest 3 bronchoscopy software update
    Johnson & Johnson MedTech announced that its Monarch bronchoscopy robot has received FDA 510(k) clearance for the latest software version, Monarch Quest 3. This marks the fourth major software laun…
    Fierce Biotech · 2d agoRegulatoryPositive↗ 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 · 3d agoPositive readoutPositive↗ source
  • Chinese biotech CEOs say US tensions won’t curb booming licensing deals
    Chinese biotech CEOs say they are not worried about rising US political tension and regulatory scrutiny. US lawmakers have increased scrutiny, referencing the America First Investment Policy and t…
    Fierce Biotech · 3d agoNeutral↗ 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 · 3d 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 · 3d agoNegative readoutNegative↗ 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 · 3d agoNegative readoutNegative↗ source
  • Evaxion drops solid tumor vaccine program to prioritize brain cancer vaccine candidate
    Evaxion Biotech announced it has discontinued development of its next‑generation solid tumor vaccine, EVX‑03, and will redirect resources toward a brain cancer vaccine candidate developed with Duke…
    Fierce Biotech · 3d agoNeutral↗ source
  • Two undisclosed gene-therapy deaths raise doubts about China's fast-track trial pathway
    Two recent deaths in China’s early‑stage gene‑therapy trials have drawn international attention. Both patients suffered severe immune reactions after receiving high‑dose viral vector treatments, an…
    Fierce Biotech · 6d agoRegulatoryNegative↗ 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 · 6d agoDealPositive↗ 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 · 7d agoPositive readoutPositive↗ 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 · 7d agoRegulatoryNeutral↗ source
  • Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal
    Taiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing up the partners to challenge Johnson & Johnson in a lung canc…
    Fierce Biotech · 7d agoNeutral↗ source
  • Zydus Sentynl signs up to $475M deal to license Mereo's phase-3 ready rare lung disease drug alvelestat in U.S.
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, announced a licensing agreement with Mereo BioPharma for the U.S. rights to alvelestat, a neutrophil elastase inhibitor that has completed…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 9d agoCRLNegative↗ source
  • FDA issues complete response letter rejecting ITM’s neuroendocrine tumor drug over manufacturing concerns
    The U.S. Food and Drug Administration sent a complete response letter to ITM Isotopes Technologies, refusing approval of its lead candidate for gastroenteropancreatic neuroendocrine tumors because…
    Fierce Biotech · 10d agoCRLNegative↗ source
  • Scholar Rock removes Novo Nordisk's Catalent plant from FDA filing for SMA drug apitegromab
    Scholar Rock announced it will no longer list Novo Nordisk’s legacy Catalent facility as a contract manufacturer in its FDA resubmission for apitegromab, its spinal muscular atrophy (SMA) candidate…
    Fierce Biotech · 10d agoRegulatoryNeutral↗ source
  • Arpeggio Biosciences shuts down after Nrf2 drug program encounters off-target toxicity
    Arpeggio Biosciences, founded in 2018 in Boulder, Colorado, built its platform around a large nascent‑RNA sequence database and aimed to develop a small‑molecule degrader of the Nrf2 transcription…
    Fierce Biotech · 10d agoLayoffsNegative↗ source
  • aTyr Pharma cuts 60% of staff to fund second phase 3 trial of lung disease drug efzofitimod
    aTyr Pharma announced it will reduce its workforce by about 60%, leaving roughly 20 employees, to reallocate resources toward its lung disease program. The cut follows the company's previous phase…
    Fierce Biotech · 10d agoLayoffsNegative↗ source
  • BlossomHill and Latigo Biotherapeutics raise over 30% beyond IPO targets
    Two emerging biotech companies surpassed their initial public offering expectations on Friday, with both BlossomHill Therapeutics and Latigo Biotherapeutics raising at least 30% more capital than p…
    Fierce Biotech · 13d agoDealPositive↗ source
  • BioNTech appoints former Sobi chief Guido Oelkers as new CEO
    BioNTech has filled its long-vacant chief executive position after a six-month search. The board selected Guido Oelkers, Ph.D., who most recently led Swedish pharmaceutical company Sobi. At Sobi,…
    Fierce Biotech · 14d agoNeutral↗ source
  • Medline recalls Hudson RCI neonatal heated wire breathing circuits over connector overheating risk
    Medline Industries announced a nationwide recall of its Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. The recall was triggered after the company received reports of sporadic failures i…
    fda medwatch · 14d agoRegulatoryNegative↗ source
  • Actimed regains full rights to S-oxprenolol, ends $126 million Faraday licensing deal
    Actimed Therapeutics announced it has reclaimed all worldwide rights to its experimental wasting disease drug S-oxprenolol, terminating the licensing agreement it had with Faraday Pharmaceuticals.…
    Fierce Biotech · 14d agoDealNeutral↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 15d agoCRLNegative↗ source