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1,533 stories matching this filter · ← front page

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  • Moderna and Merck vaccine plus Keytruda cuts melanoma relapse risk by 42% in late-stage trial
    A late-stage adjuvant study of Moderna’s experimental melanoma vaccine, intismeran autogene, combined with Merck’s Keytruda showed a 42% reduction in the risk of relapse or death compared with Keyt…
    BioPharma Dive · 24d agoPositive readoutNeutral↗ source
  • AbbVie’s HS drug lutikizumab meets Phase 3 goal but falls short of analyst expectations
    AbbVie reported that its investigational IL‑1α/β inhibitor lutikizumab achieved the primary endpoint in the Phase 3 INTREPID study for hidradenitis suppurativa, a chronic inflammatory skin disease…
    BioSpace · 24d agoNegative readoutNegative↗ source
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  • Merck and Moderna cancer vaccine data leak shows modest benefit, shares slide
    A data leak ahead of the European Society of Medical Oncology meeting revealed early results for the personalized cancer vaccine intismeran autogene combined with Merck's Keytruda. The information…
    BioSpace · 24d agoNegative readoutNegative↗ source
  • FDA accepts new submission for Biohaven’s Vyglxia, opening path to approval
    Biohaven announced that the FDA has accepted a refreshed application for its rare disease drug Vyglxia, which targets a nerve‑damaging disorder. Vyglxia is being developed for spinocerebellar atax…
    BioPharma Dive · 24d agoRegulatoryPositive↗ source
  • Compounding pharmacy recalls copycat version of Eli Lilly’s Zepbound amid safety concerns
    Apothecary Pharma, a compounding pharmacy, has voluntarily recalled its compounded tirzepatide product that mimics Eli Lilly's obesity drug Zepbound. The company said it could not guarantee the saf…
    BioPharma Dive · 24d agoCRLNegative↗ source
  • Biohaven's ataxia drug resubmission accepted by FDA, shares surge 36%
    Biohaven’s experimental drug troriluzole, being developed for spinocerebellar ataxia, was previously rejected by the FDA because the agency questioned the design of the registrational trial. The co…
    BioSpace · 24d agoRegulatoryPositive↗ source
  • Roche reaffirms sales outlook despite weaker Xolair sales and looming generic competition
    Roche reported third-quarter group sales of 16.1 billion Swiss francs, about $19.6 billion, a 7% increase that beat analysts' consensus estimate of 15.8 billion francs. The beat was helped by a ne…
    BioPharma Dive · 24d agoEarningsNegative↗ source
  • Biotech sector logs 31 IPOs in 2026, with four more slated, still far below 2021 boom
    Biotech IPO activity has accelerated this year, with 31 companies completing public offerings so far, according to BioSpace data. This figure exceeds the totals from each of the previous four year…
    BioSpace · 24d agoDealNeutral↗ source
  • Investors Re-evaluate Kidney Disease as New Cell and Gene Therapy Strategies Emerge
    In a recent episode of BioSpace's Denatured podcast, the CEOs of ProKidney and Nephrogen discussed why kidney disease has long been a difficult indication for cell and gene-based medicines. The co…
    BioSpace · 24d agoPositive↗ source
  • Merck to showcase three late-stage TROP2 ADC trials at ESMO 2026, VP says payload is in the "Goldilocks zone"
    At the European Society for Medical Oncology meeting in 2026, Merck will present three late-stage trials of its TROP2‑directed antibody‑drug conjugate sac‑TMT, developed in partnership with Kelun‑B…
    BioSpace · 24d agoPositive↗ source
  • Biopharma firms curb hiring as $100,000 H-1B visa fee limits foreign talent
    The U.S. Department of Homeland Security’s recent increase of the H-1B visa filing fee to $100,000 has made it much more expensive for biopharma employers to sponsor foreign-born scientists and eng…
    BioSpace · 24d agoRegulatoryNeutral↗ source
  • Roche’s pipeline trim claims Poseida’s off-the-shelf CAR T asset
    Aside from RG6540, Roche also discontinued a host of other early-stage assets, including an antisense oligonucleotide for Alzheimer’s disease and a small-molecule candidate for geographic atrophy.
    BioSpace · 24d agoRegulatoryNeutral↗ source
  • Key career moves that propelled three BioSpace 40 Under 40 honorees to biotech leadership
    BioSpace highlighted three members of its 40 Under 40 list, asking them to describe pivotal moments that shaped their biotech careers. Lex Johnson, chief platform officer at Dispatch Bio, said the…
    BioSpace · 24d agoPositive↗ source
  • Natural Grocers recalls 2‑pound organic mung beans over possible glass contamination
    Vitamin Cottage Natural Food Markets, Inc. in Lakewood, Colorado announced a recall of Natural Grocers brand organic 2‑pound mung beans because of potential glass contamination. The recall follows…
    fda recalls · 23d agoRegulatoryNegative↗ source
  • WinCo Foods recalls hoagie rolls after undisclosed sesame ingredient
    WinCo Foods of Boise, Idaho announced a recall of its brand hoagie rolls because sesame was not listed on the label. The rolls, identified by UPC 2-70552-00649-2 and bearing best-by dates from Sep…
    fda recalls · 24d agoCRLNeutral↗ source
  • GSK and Ionis receive FDA nod for Hibsago, a potential functional cure for chronic hepatitis B
    The U.S. Food and Drug Administration has cleared Hibsago, a collaborative product of GSK and Ionis, as the first therapy of its kind aimed at chronic hepatitis B. The medicine is to be added to s…
    BioPharma Dive · 25d agoApprovalPositive↗ source
  • US patients skip half of new high-cost drugs as prices surge past $250K
    A new report from the Institute for Clinical and Economic Review and West Health finds that only about one-third of patients prescribed newly launched medicines actually fill them within 30 days, w…
    BioSpace · 25d agoNegative↗ source
  • Roivant's brepocitinib shows strong Phase 3 results, paving way for uveitis indication
    Roivant subsidiary Priovant Therapeutics announced positive Phase 3 data for its anti‑inflammatory drug brepocitinib in patients with non‑infectious uveitis, an eye disease that can cause blindness…
    BioPharma Dive · 25d agoRegulatoryPositive↗ source
  • FDA approves GSK‑Ionis hepatitis B functional cure, Hibsago, targeting undetectable virus after six months
    The FDA has approved bepirovirsen, an antisense oligonucleotide from GSK and Ionis, for chronic hepatitis B infection. It will be sold under the brand name Hibsago. The therapy is described as a f…
    BioSpace · 25d agoApprovalPositive↗ source
  • US biotech M&A surges as Chinese licensing deals dominate 2026 market
    Locust Walk reports that China now accounts for 58% of global licensing deal value in 2026, while the United States share has dropped to 26%. Despite the licensing shift, US biotech companies are…
    BioSpace · 25d agoDealPositive↗ source
  • Disc Medicine’s Phase 3 data revives rejected rare‑disease drug as China tightens biotech ownership rules
    Disc Medicine announced that its Phase 3 trial of a previously rejected rare‑disease therapy showed positive results, effectively rescuing the program and positioning it for another submission to t…
    BioSpace · 25d agoPositive readoutPositive↗ source
  • Novo reports 25% average weight loss in women using CagriSema, with greatest loss in premenopausal patients
    Novo's next-generation GLP-1 drug CagriSema showed substantial weight loss in women enrolled in the Phase 3 REDEFINE 1 trial. Women in the study lost about 25% of their body weight after 68 weeks,…
    BioSpace · 25d agoPositive readoutPositive↗ source
  • Wedgewood Pharmacy recalls multiple compounded veterinary meds over potency testing inconsistencies
    Wedgewood Pharmacy LLC announced a recall of certain compounded veterinary medications that are still within their expiration dates. The recall is due to inconsistencies in the reliability of anal…
    fda recalls · 25d agoCRLNegative↗ source
  • FDA cites Baxter’s inadequate oversight after repeated GMP violations at multiple plants
    The U.S. Food and Drug Administration has issued a warning letter to Baxter International, saying the company's leadership has failed to provide adequate oversight of its drug manufacturing operati…
    BioSpace · 25d agoRegulatoryNegative↗ source
  • Arcus kidney cancer drug shows stronger potency than Merck's Welireg, boosting shares
    Arcus Biosciences reported follow‑up data from its late‑stage kidney cancer trial that suggest its experimental therapy, casdatifan, may be more potent than Merck's approved drug Welireg. Analysts…
    BioPharma Dive · 25d agoPositive readoutPositive↗ source