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2,338 stories matching this filter · ← front page

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  • Eden Brothers recalls Calabrese broccoli seeds over possible Salmonella contamination
    Eden Brothers LLC announced a recall of its Calabrese broccoli seeds after being informed by its supplier that the product may be contaminated with Salmonella. The recall includes 1‑ounce and 1‑po…
    fda recalls · 14d agoCRLNegative↗ source
  • Epkinly shows 51% PFS boost in frontline DLBCL, may become new standard of care
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a substantial gain in progression‑free survival when added to the standard R‑CHOP regimen in newly diagnosed diffuse large…
    BioSpace · 16d agoPositive readoutPositive↗ source
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  • AbbVie and Genmab's Epkinly succeeds in late-stage first-line DLBCL trial, challenging Roche's Polivy
    AbbVie and Genmab announced that their T‑cell engager Epkinly met its primary endpoints in a late‑stage study evaluating first‑line treatment for diffuse large B‑cell lymphoma (DLBCL). The trial de…
    Endpoints · 16d agoPositive readoutPositive↗ source
  • Forbion raises €2.3 billion with Lilly backing, launches largest Dutch VC fund to back ~30 life-science firms
    Forbion, a Netherlands-based life-science investor, announced it has closed two new funds totaling €2.3 billion ($2.6 billion), the largest capital raise in Dutch venture-capital history. The fund…
    Endpoints · 16d agoDealPositive↗ source
  • AstraZeneca opens 570,000-sq-ft R&D campus in Cambridge, targeting 2,000 staff
    AstraZeneca inaugurated a new research and development building in Cambridge, Massachusetts on Monday. The facility spans 570,000 square feet and is expected to house about 2,000 employees once fu…
    Endpoints · 15d agoPositive↗ source
  • ArriVent's lead lung cancer drug firmonertinib fails Phase 3 trial, shares plunge
    ArriVent BioPharma announced that its flagship EGFR inhibitor, firmonertinib, did not meet primary endpoints in a late-stage Phase 3 study for lung cancer. The trial results were released on Octobe…
    Endpoints · 15d agoNegative readoutNegative↗ source
  • Compliance worries keep AI adoption in drug manufacturing low, survey finds
    A new survey of more than 400 research and manufacturing professionals shows that over 90% of drugmakers have not committed to expanding AI use in regulated drug production. While AI is widely em…
    BioSpace · 16d agoRegulatoryNegative↗ source
  • AI investments in healthcare delivering returns faster than executives anticipated
    A new report from Bessemer Venture Partners finds that artificial-intelligence projects in health-care are delivering benefits more quickly than industry leaders expected. The survey highlights th…
    Endpoints · 16d agoPositive↗ source
  • Lycia Therapeutics files for IPO to fund antibody degrader platform
    Lycia Therapeutics, a protein‑degradation startup built on research from Nobel laureate Carolyn Bertozzi, announced it has filed for an initial public offering. The filing is intended to raise cap…
    Endpoints · 16d agoDealNeutral↗ source
  • BioSpace honors 40 emerging leaders shaping biopharma with breakthroughs in mRNA, gene and cell therapies
    BioSpace announced its latest 40 Under 40 cohort, recognizing young professionals who have made notable contributions across biopharma. The honorees span a range of roles, from scientific innovator…
    BioSpace · 16d agoPositive↗ source
  • UK regulator adopts AI framework for medical devices and launches third AI Airlock phase
    The Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK government has adopted a set of recommendations on the use of artificial intelligence in medical devices. These…
    raps · 16d agoRegulatoryNeutral↗ source
  • Utah expands AI prescribing sandbox to boost health‑tech innovation
    Utah is positioning itself as a national leader in the use of artificial intelligence for healthcare, according to recent reporting. The state’s Office of AI Policy runs a regulatory sandbox that…
    Endpoints · 15d agoRegulatoryPositive↗ source
  • 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 · 16d agoDealPositive↗ source
  • UK regulator adopts AI framework for medical devices, launches next phase of AI sandbox
    The Medicines and Healthcare products Regulatory Agency announced that the UK government has accepted a set of recommendations on using artificial intelligence in medical devices. These recommendat…
    raps · 16d agoRegulatoryPositive↗ 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 · 16d agoCRLNegative↗ source
  • WHO releases updated draft guideline to strengthen quality risk management for manufacturers and regulators
    The World Health Organization has issued an updated draft guideline designed to help manufacturers establish effective quality risk management systems and to aid regulators in planning inspections.…
    raps · 16d agoRegulatoryNeutral↗ source
  • 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 · 17d 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 · 17d 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