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2,020 stories matching this filter · ← front page

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  • KymaThera secures $80M Series B to advance oral PI3Kα inhibitor K-1728 as biotech peers raise funds and go public
    KymaThera, a San Diego biotech, announced an $80 million Series B round to fund development of its pan-mutant selective PI3Kα inhibitor, K-1728. The oral candidate is planned to enter Phase 1 clin…
    Endpoints · 15d agoDealPositive↗ source
  • Leader Formulas recalls RAPTURE pre-workout supplement after FDA finds DMAA in product
    Leader Formulas, LLC of Tomball, Texas announced a voluntary nationwide recall of one lot of its RAPTURE pre‑workout powder after testing revealed the presence of the stimulant 1,3‑dimethylamylamin…
    fda recalls · 15d agoCRLNegative↗ source
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  • Pacific Health Sciences recalls Baby Sleep Gripe Water over undeclared alcohols
    Pacific Health Sciences announced a voluntary recall of one lot of its Babies' Magic Tea brand Baby Sleep Gripe Water dietary supplement. FDA testing identified undeclared ethanol, methanol and is…
    fda recalls · 15d agoCRLNegative↗ source
  • Secretive new issue links diverse groups, raises concerns for pharma industry
    The article, dated October 6, 2026, was written by senior reporter Max Bayer and carries the title “In DC, a secretive new thorn has appeared in pharma’s side.” It notes that the Seattle Latino Ch…
    Endpoints · 15d agoNegative↗ source
  • Shionogi makes $2B rare disease play with IntraBio buy
    With its acquisition of IntraBio, Shionogi will gain ownership over Aqneursa, which could hit peak global sales of $1 billion across its two indications in Niemann-Pick disease type C and ataxia-te…
    BioSpace · 15d ago↗ source
  • FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues
    Despite the regulatory delay, Novo is still expecting a 2027 launch for its hemophilia A drug denecimig.
    BioSpace · 15d ago↗ source
  • Vaxcyte's experimental pneumococcal vaccine VAX-31 meets Phase 3 endpoints, shares jump 35%
    Vaxcyte announced that its experimental pneumococcal vaccine VAX-31 achieved its primary objectives in a Phase 3 trial involving adult participants. The trial results showed that the vaccine met t…
    Endpoints · 16d agoPositive readoutPositive↗ source
  • Vaxcyte’s VAX-31 shows superior results in Phase 3, beating Pfizer and Merck’s pneumococcal vaccines and sparking $8 bn market hopes
    Vaxcyte reported that its investigational pneumococcal conjugate vaccine, VAX-31, met the co-primary endpoints in a Phase 3 trial, demonstrating non-inferiority to the existing shots from Pfizer an…
    BioSpace · 16d agoPositive readoutPositive↗ source
  • Genentech signs up to develop Alector’s preclinical blood-brain barrier therapy in $1.27 billion deal
    Genentech, a Roche subsidiary, announced a deal with Alector to obtain exclusive rights to its preclinical blood-brain barrier delivery asset, AL050. The agreement provides $100 million upfront an…
    BioSpace · 16d agoDealPositive↗ source
  • FDA urged to boost US access to new and experimental drugs as trials shift to China
    The piece highlights that the FDA has taken steps such as launching Operation TrialBlazer and tightening review of foreign clinical data, but argues that further action is required to keep the Unit…
    BioSpace · 16d agoRegulatoryNegative↗ source
  • Lilly adds $870M to Gate Bioscience partnership to pursue new drug targets
    Eli Lilly is expanding its collaboration with Gate Bioscience, adding a new financial commitment of more than $870 million. The original July 2025 agreement gave Lilly access to Gate’s "Molecular…
    BioSpace · 16d agoDealPositive↗ source
  • Shionogi agrees $2 billion upfront purchase of IntraBio, adding oral rare-disease drug Aqneursa to its portfolio
    Shionogi announced it will acquire Austin-based biotech IntraBio for $2 billion paid upfront. The deal brings IntraBio’s oral therapy Aqneursa into Shionogi’s rare‑disease pipeline, expanding its…
    Endpoints · 16d agoDealPositive↗ source
  • Nova Biomedical issues global correction for StatStrip Glucose Hospital Meter over software patient-ID error
    Nova Biomedical announced a global medical device correction for its StatStrip Glucose Hospital Meter System. The correction targets a software issue in the Gen 2.0 model that can leave prior pati…
    fda recalls · 15d agoCRLNegative↗ source
  • Leerink analyst downgrades Bristol Myers over pipeline concerns
    A Leerink analyst signaled new bearishness on Bristol Myers Squibb, downgrading the company's stock rating. Analyst David Risinger moved the rating from outperform to a lower stance, saying he is…
    Endpoints · 16d agoNegative↗ source
  • Viking Therapeutics jumps 24% after Phase 1 obesity data, Longeveron falls 64% on mid-stage setback
    In September biotech stocks showed wide swings, with Viking Therapeutics gaining 24% and Longeveron dropping 64% as investors reacted to clinical data and trial setbacks. Viking reported Phase 1 r…
    BioSpace · 16d agoPositive readoutNeutral↗ source
  • Genmab reports 45.9% response rate for FRα‑directed ADC in platinum‑resistant ovarian cancer; Lilly expands Jaypirca label
    Genmab presented new data on its FRα‑targeted antibody‑drug conjugate Rina‑S in patients with platinum‑resistant ovarian cancer. In the trial, the ADC achieved an objective response rate of 45.9%,…
    Endpoints · 16d agoPositive readoutPositive↗ source
  • Roche signs $100 million upfront deal with Alector to advance Parkinson's research
    Roche announced a partnership with biotech Alector focused on neuroscience and Parkinson's disease, providing an upfront cash payment of $100 million. The agreement aims to combine Roche's resourc…
    Endpoints · 16d agoDealPositive↗ source
  • Biogen's litifilimab shows clear or almost clear skin in cutaneous lupus after one year
    Biogen reported that its experimental antibody litifilimab produced clear or almost clear skin in patients with cutaneous lupus erythematosus after one year of treatment in a mid‑stage study. The r…
    BioSpace · 16d agoPositive readoutPositive↗ source
  • Nobel prize honors scientists who pioneered light-activated gene therapy technology
    Three researchers received this year’s Nobel Prize in medicine for creating optogenetics, a technique that uses light to steer nerve activity. The award recognizes their foundational work that has…
    Endpoints · 16d agoPositive↗ source
  • Sensible Bio raises $47 million Series A to build mRNA therapy manufacturing platform
    Sensible Biotechnologies announced it has closed a $47 million Series A financing round. The capital will be used to develop its proprietary manufacturing platform for mRNA based therapies. The fu…
    Endpoints · 16d agoDealPositive↗ source
  • Epicrispr reports encouraging early data from EPI-321 in 12 patients with FSHD
    Epicrispr Biotechnologies released updated data on its epigenetic editing therapy EPI-321 aimed at treating facioscapulohumeral muscular dystrophy (FSHD). The company has now dosed twelve particip…
    Endpoints · 16d agoPositive readoutPositive↗ source
  • Kyverna Therapeutics reports encouraging data for first CAR-T therapy targeting autoimmune disease
    Kyverna Therapeutics released new data that strengthens its case for bringing the first CAR‑T treatment for an autoimmune condition to market. The results come after recent safety setbacks in simil…
    BioSpace · 16d agoPositive readoutNeutral↗ source
  • Roivant Sciences launches first solo drug, Lisraya, after FDA approval for dermatomyositis
    Roivant Sciences, which operates a hub-and-spoke subsidiary model, is stepping into the commercial arena with its inaugural solo product launch. The FDA has granted approval to the oral TYK2/JAK i…
    BioSpace · 16d agoApprovalPositive↗ source
  • CSL agrees $355M upfront deal to co-develop Alentis anti-fibrosis drug for kidney and liver
    CSL, an Australian drugmaker, announced a partnership with Alentis Therapeutics that includes a $355 million upfront payment. Under the agreement, CSL will co-develop Alentis's anti-fibrosis candi…
    Endpoints · 16d agoDealNeutral↗ source
  • FDA delays review of Novo's hemophilia A drug denecimig over factory issues
    US regulators have extended the review of Novo's hemophilia A injection, denecimig, because of problems at an unnamed manufacturing facility. The FDA said ongoing remediation activities observed d…
    Endpoints · 16d agoRegulatoryNegative↗ source