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1,205 stories matching this filter · ← front page

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  • Genmab’s bispecific antibody petosemtamab plus Keytruda cuts death risk by half in Phase 3 head‑and‑neck cancer trial
    Genmab announced that its bispecific antibody petosemtamab, combined with Merck’s Keytruda, met both co‑primary endpoints in a Phase 3 trial for head‑and‑neck squamous cell carcinoma. The LiGeR‑HN…
    BioSpace · 13d agoPositive readoutPositive↗ source
  • Big pharma holds $188 bn for M&A, J&J seen as most likely buyer, analysis shows
    The latest Leerink Partners analysis finds that the largest pharmaceutical companies collectively have about $188 billion in cash available for mergers and acquisitions. All but one of the firms su…
    BioSpace · 13d agoDealPositive
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fda medwatch111
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Psychiatry & CNS1204
Ophthalmology1050
Endocrinology & Metabolism775
Pain775
Nephrology759
↗ source
  • FDA issues draft guidance to streamline approval of personalized gene therapies and expands CMS access model
    The Food and Drug Administration released a draft guidance that lets a single biologics license application cover multiple variants of a gene‑therapy product. The guidance introduces an Individuali…
    BioSpace · 13d agoRegulatoryPositive↗ source
  • Astellas signs up to $1.34 billion option deal for Audax's DAX-044 immuno-oncology candidate
    Astellas Pharma announced it will pay up to $1.34 billion for an exclusive option to license Audax Biosciences' investigational antibody-cytokine fusion, DAX-044. The agreement includes an undiscl…
    BioSpace · 13d agoDealPositive↗ source
  • Biogen sees continued revenue growth and pipeline readouts, M&A not essential, CEO says
    Biogen reported third‑quarter earnings, marking a third straight quarter of revenue growth driven by its marketed products. The increase stemmed from higher sales of the Alzheimer’s therapy Leqemb…
    BioSpace · 13d agoEarningsPositive↗ source
  • Biogen posts third consecutive quarter of revenue growth, driven by Leqembi, Spinraza and Apellis products
    Biogen reported $2.8 billion in revenue for the third quarter, marking its third straight period of top‑line growth. The company credited its growth portfolio, led by the Alzheimer’s therapy Leqem…
    BioSpace · 13d agoEarningsPositive↗ source
  • Five newly approved drugs achieve strong launches by offering superior efficacy, pricing and access
    Over the past year several newly approved therapies have entered the market with sales and uptake that far exceed analyst expectations, driven by strong clinical data, reasonable pricing and easy p…
    BioSpace · 13d agoPositive↗ source
  • Biotech firms must adopt global regulatory strategies to commercialize drugs independently
    Biotech developers are increasingly able to fund the pursuit of regulatory approval and commercial launch on their own, rather than selling their assets early. This new option is driven by a reboun…
    BioSpace · 13d agoRegulatoryPositive↗ source
  • Merck and Moderna vaccine data leak ahead of ESMO, Merck's sac-TMT cuts endometrial cancer deaths, BMS reports CAR-T death
    A data leak of the highly anticipated personalized cancer vaccine being developed by Merck and Moderna surfaced online before the European Society for Medical Oncology (ESMO) meeting. The premature…
    BioSpace · 13d agoNeutral↗ source
  • Former Novo and Sanofi staff describe mixed layoff experiences, citing severance benefits and poor communication
    Three former employees of large pharmaceutical companies, including Novo and Sanofi, spoke to BioSpace about how they were let go. Their accounts form part of a broader survey that collects layoff…
    BioSpace · 13d agoLayoffsNegative↗ source
  • GSK vaccine sales miss expectations amid falling demand from adults
    With pressure on GSK’s vaccine business, analysts predict the U.K. pharma will face challenges as it prepares for the loss of exclusivity on a key product.
    BioSpace · 13d agoRegulatoryNeutral↗ source
  • FDA issues draft guidance for electronic IDE submissions via eSTAR
    The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
    raps · 13d agoRegulatoryNeutral↗ source
  • Biopharma leader urged to prioritize own job search after team layoffs
    A biopharma executive recently had to announce a downsizing of her team, and she described feeling guilt and grief for the impact on her direct reports. She said she would wait until every person…
    BioSpace · 13d agoLayoffsNeutral↗ source
  • Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
    Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.
    BioSpace · 13d ago↗ source
  • Lilly’s retatrutide trounces Novo’s Ozempic in diabetes, weight loss
    Eli Lilly’s next-gen weight loss drug retatrutide soundly beat Novo’s approved medicine Ozempic in weight loss and blood sugar reduction, padding the case for a regulatory application that’s expect…
    BioSpace · 13d ago↗ source
  • Incyte's KRAS G12D inhibitor shows 89% response rate in early pancreatic cancer trial
    In a Phase 1 study, Incyte tested its KRAS G12D inhibitor together with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma carrying the G12D mutation. The combinati…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • Novartis takes $1.9B write-down after Avidity's del-desiran fails Phase 3 but reaffirms confidence in $12B acquisition
    Novartis announced a $1.9 billion partial impairment after the Phase 3 HARBOR study of del-desiran, an antibody‑oligonucleotide conjugate from its Avidity Biosciences acquisition, did not meet its…
    BioSpace · 14d agoNegative readoutNeutral↗ source
  • FDA releases draft guidance on oversight of individualized gene-editing products
    The U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…
    raps · 14d agoRegulatoryNeutral↗ source
  • Alphabet’s GV tops biotech corporate investors with $5.23 billion in deals since 2025
    Alphabet’s venture arm GV has become the largest corporate spender in biotech, investing a cumulative $5.23 billion across 20 deals since the start of 2025. The total outlay exceeds the combined v…
    BioSpace · 14d agoNeutral↗ source
  • FDA issues early alert on B. Braun Streamline Bloodline Set recall due to connector leak risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert about B. Braun's Streamline Bloodline Set for Dialog+ after discovering a potential high risk issue. The problem is trace…
    fda medwatch · 14d agoCRLNegative↗ source
  • FDA approves prostate cancer and Crohn’s disease therapies as judge rejects effort to block Lilly weight‑loss ads
    The U.S. Food and Drug Administration announced approvals for new treatments targeting prostate cancer and Crohn’s disease. The decisions expand therapeutic options for patients with these conditio…
    raps · 14d agoRegulatoryNeutral↗ source
  • FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech Conference
    At the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…
    raps · 14d agoRegulatoryNeutral↗ source
  • After 2 patient deaths and cell therapy durability concerns, Artiva cuts 94% of workforce
    Artiva Biotherapeutics, which had been evaluating cell therapy AlloNK for the treatment of rheumatoid arthritis and other autoimmune diseases, is exploring strategic options that could include diss…
    BioSpace · 14d ago↗ source
  • Amgen’s Imdelltra plus AstraZeneca’s Imfinzi cuts death risk by ~60% in extensive-stage small cell lung cancer
    Amgen presented Phase 3 data at ESMO 2026 showing that its bispecific T‑cell engager Imdelltra, when added to AstraZeneca’s checkpoint inhibitor Imfinzi, significantly reduced mortality in extensiv…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • Genmab’s Rina-S ADC cuts risk of progression and death in Phase 3 ovarian cancer trial
    Genmab reported results from its Phase 3 RAINFOL-02 trial of the FRα‑directed antibody‑drug conjugate Rina‑S (rinatabart sesutecan) in patients with platinum‑resistant ovarian cancer. In the inten…
    BioSpace · 15d agoPositive readoutPositive↗ source