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1,514 stories matching this filter · ← front page

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  • TRex Bio targets $111M IPO as Retension and Lycia also prepare public listings
    TRex Bio, backed by Eli Lilly, filed with the SEC to raise about $111.3 million by offering 8.3 million shares priced between $14 and $16. If the midpoint price is achieved, the company expects net…
    Fierce Biotech · 15d agoDealNeutral↗ source
  • UK regulator to shift from one-off checks to continuous monitoring of AI medical devices
    The UK’s Medicines and Healthcare products Regulatory Agency announced a new policy that will require continuous monitoring of AI‑driven medical devices, replacing the current one‑time review model…
    Fierce Biotech · 15d agoRegulatoryPositive↗ source
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  • Caribou Biosciences halts pipeline and announces major workforce cut
    Caribou Biosciences, a Bay Area biotech that develops off-the-shelf CAR-T cell therapies, said it will stop all clinical development and begin a substantial workforce reduction. The company, which…
    Fierce Biotech · 14d agoLayoffsNegative↗ 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 · 15d agoRegulatoryNegative↗ source
  • ArriVent’s phase 3 EGFR inhibitor trial misses primary endpoint, shares plunge 57%
    ArriVent BioPharma reported results from its phase 3 Furvent trial, which evaluated firmonertinib, a brain-penetrant EGFR inhibitor, in patients with exon 20 insertion-mutated non-small cell lung c…
    Fierce Biotech · 15d agoNegative readoutNegative↗ source
  • Kairos pushes prostate cancer drug ENV-105 into earlier treatment line after promising mid-phase data
    Kairos Pharma announced a change to its phase 2 trial of ENV-105, a prostate cancer candidate, moving it to an earlier line of therapy. The modified protocol will enroll patients whose PSA rises a…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Abbott receives FDA clearance for CardioMEMS HF System updates enabling home pressure monitoring via smartphone app
    Abbott announced that the U.S. Food and Drug Administration has cleared updated software for its CardioMEMS HF System. The changes add a patient facing component through the CardioGuide HF mobile a…
    Fierce Biotech · 15d agoApprovalPositive↗ source
  • AstraZeneca opens 570,000-sq-ft Kendall Square R&D hub to boost cancer and biotech research
    AstraZeneca inaugurated a 570,000-square-foot research and development facility in Kendall Square, Cambridge, Massachusetts. The 18-story building will host roughly 2,000 scientists working on chr…
    Fierce Biotech · 15d agoPositive↗ 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 · 15d 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 · 15d agoRegulatoryNeutral↗ 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 · 15d 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 · 15d 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 · 15d agoRegulatoryNeutral↗ source
  • Nuvig Therapeutics pauses CIDP trial of NVG-2089, cites enrollment and cost challenges
    Nuvig Therapeutics, backed by major pharmaceutical partners, announced it is stopping development of its lead fusion protein NVG-2089 for chronic inflammatory demyelinating polyradiculoneuropathy (…
    Fierce Biotech · 15d agoNegative↗ 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
  • 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 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
  • FDA approves first expandable pediatric pulmonary heart valve
    The FDA has cleared a new surgically implanted pulmonary valve designed for children with congenital pulmonary valve disease. The device, called the Autus Size-Adjustable Valve, was developed by E…
    Fierce Biotech · 16d agoApprovalPositive↗ 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
  • Vaxcyte’s 31-valent pneumococcal vaccine shows non-inferior immunity to Pfizer and Merck shots in Phase 3, shares surge
    Vaxcyte’s 31-valent pneumococcal candidate, VAX-31, was compared head‑to‑head with Pfizer’s Prevnar 20 and Merck’s Capvaxive in the late‑stage Opus‑1 study aimed at preventing invasive pneumococcal…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • CSL pays $355M upfront to co-develop Alentis’ phase-2 fibrosis drug lixudebart
    CSL of Australia has agreed to pay $355 million upfront for the rights to Alentis Therapeutics' anti-Claudin-1 drug lixudebart, a phase-2 fibrosis candidate. The agreement includes up to $1.2 bill…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Genmab’s Rina-S ADC shows 9.5-month median PFS, touted as superior to AbbVie’s Elahere
    Genmab reported median progression‑free survival of 9.5 months for its FRα‑directed antibody‑drug conjugate Rina‑S in part C of the phase 1/2 Rainfol‑01 trial, which enrolled 109 patients with plat…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source