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1,232 stories matching this filter · ← front page

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  • AbbVie halts development of livmoniplimab after deeming benefit limited
    AbbVie announced it is discontinuing the phase 2 development of its monoclonal antibody livmoniplimab (ABBV-151) after concluding the drug is unlikely to outperform existing therapies. The drug wa…
    Fierce Biotech · 9d agoNegative↗ source
  • Stakeholders submit over 500 comments urging FDA to shape regulation of generative AI medical devices
    Over 500 comments have been filed in response to the FDA's discussion paper on generative AI-enabled medical devices. The feedback reflects a wide range of viewpoints. Some participants recommend…
    raps · 9d agoRegulatoryNeutral↗ source
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  • GE HealthCare launches Allia Celeo ceiling-mounted AI image guidance system at TCT 2026
    GE HealthCare introduced a new imaging product called Allia Celeo. The system is mounted on the ceiling and uses artificial intelligence to guide image acquisition during procedures. The debut…
    Fierce Biotech · 9d agoPositive↗ source
  • Recon: Merck KGaA to exit CDMO business; Karyopharm to sell itself in bankruptcy
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 9d ago↗ source
  • FDA places uniQure’s Huntington’s gene therapy in priority review, targeting May 2027 approval
    The U.S. Food and Drug Administration has accepted uniQure’s filing for its Huntington’s disease gene therapy and placed the product under priority review, a step that could accelerate a decision b…
    Fierce Biotech · 10d agoRegulatoryPositive↗ source
  • InventisBio's Phase 3 Trial Shows Nomelcitinib Achieves Over 70% PASI-90 Response in Chinese Psoriasis Patients
    InventisBio, a Shanghai‑based biotech, completed a phase 3 study of its TYK2 inhibitor nomelcitinib in 391 Chinese patients with moderate to severe psoriasis. Participants were randomized to receiv…
    Fierce Biotech · 10d agoPositive readoutPositive↗ source
  • FDA issues final guidance on potency standards for cell and gene therapy developers
    The U.S. Food and Drug Administration released a final guidance on Monday that sets out the expectations for sponsors of cell and gene therapies to demonstrate product potency. The document requir…
    raps · 10d agoRegulatoryNeutral↗ source
  • Karyopharm files Chapter 11 and taps Irish biotech Ayrmid as lead bidder for merger
    Karyopharm Therapeutics, a Massachusetts-based biopharma, entered Chapter 11 bankruptcy as part of a plan to merge with Irish hematology biotech Ayrmid. The move follows a cash crisis revealed in…
    Fierce Biotech · 10d agoDealNegative↗ source
  • Biossil Labs acquires Theriva's antibiotic-degrader portfolio in up to $91 million deal
    Biossil Labs, a Canadian biotech backed by OpenAI, announced a deal to acquire Theriva Biologics' early- to mid-stage portfolio of antibiotic‑degrading enzymes for a total potential value of up to…
    Fierce Biotech · 10d agoDealNeutral↗ source
  • FDA places partial hold on Bright Minds' seizure trial over mouse toxicity concerns
    The FDA issued a partial clinical hold on Bright Minds Biosciences' planned phase 2 trial of BMB-101 in patients with developmental and epileptic encephalopathies. The hold was triggered by precli…
    Fierce Biotech · 10d agoRegulatoryNegative↗ source
  • Teva halts phase 2 trial of emrusolmin for multiple system atrophy after futility analysis
    Teva Pharmaceuticals announced it is stopping a phase 2 study of its experimental small‑molecule drug emrusolmin, which was being tested in patients with the rare neurodegenerative condition multip…
    Fierce Biotech · 10d agoNegative readoutNegative↗ source
  • Tiziana's intranasal MS drug shows lower dose cuts neuroinflammation, higher dose falls short in Phase 2a trial
    Tiziana Life Sciences reported results from its mid‑stage Inform‑MS trial, a Phase 2a study that enrolled 48 patients with non‑active secondary progressive multiple sclerosis. Participants received…
    Fierce Biotech · 10d agoPositive readoutNeutral↗ source
  • FDA approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concerns
    The U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.…
    raps · 10d agoApprovalNeutral↗ source
  • Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+
    The dialyzer connector may not be attached appropriately, resulting in leaking and potential blood loss.
    fda medwatch · 10d agoRegulatoryNeutral↗ source
  • Study finds patient agreement forms match knowledge surveys, urging greater transparency in FDA’s mifepristone REMS
    A randomized controlled trial published in JAMA Internal Medicine examined how well patients understood medication abortion when they signed the FDA’s risk evaluation and mitigation strategy (REMS)…
    raps · 10d agoRegulatoryNeutral↗ source
  • Australian regulator opens consultation on clinical trial data sharing and ICH GCP guidance
    The Therapeutic Goods Administration (TGA) in Australia has launched a public consultation seeking input on how clinical trial information should be shared under existing schemes. The consultation…
    raps · 10d agoRegulatoryNeutral↗ source
  • FDA warns against Once Upon a Farm Tractor Wheels toddler bars due to choking risk
    The U.S. Food and Drug Administration issued a consumer safety advisory concerning the organic toddler snack Once Upon a Farm Tractor Wheels. The agency cautioned that the soft‑baked bars pose a p…
    fda medwatch · 10d agoRegulatoryNegative↗ source
  • MedWatch Alert: FDA Advises Consumers Not to Buy or Serve Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked Bars
    Consumers Should Not Buy or Serve Once Upon a Farm Tractor Wheels, Organic Toddler Soft-Baked Bars Due to a Potentially Fatal Choking Hazard
    fda medwatch · 10d ago↗ source
  • Instrumentation Laboratories recalls several lots of HemosIL AcuStar HIT-IgG(PF4-H) assay due to false-negative risk
    Instrumentation Laboratories (Werfen) has issued a recall of specific lots of its HemosIL AcuStar HIT-IgG(PF4-H) radioimmunoassay after the FDA identified a performance issue that could produce fal…
    fda medwatch · 13d agoCRLNegative↗ source
  • Sanofi eyes 'moonshot' drug acquisitions to offset upcoming Dupixent patent loss
    Sanofi's CFO Francois-Xavier Roger told Fierce that the company is looking at 'moonshot' treatments as potential acquisition targets to rebuild its pipeline. The push comes as the U.S. patent on D…
    Fierce Biotech · 13d agoDealNeutral↗ source
  • Bracco to invest $230M in new US contrast media plant, creating 200 jobs
    Bracco Diagnostics announced a $230 million investment to build its first U.S. manufacturing facility for injectable contrast media in Sanford, North Carolina. The plant is slated to create about…
    Fierce Biotech · 13d agoDealPositive↗ source
  • Nova Biomedical issues safety instructions for StatStrip Glucose Hospital Meter Gen 2.0
    Nova Biomedical has sent a letter to customers using the StatStrip Glucose Hospital Meter System Gen 2.0, advising updated use instructions while a software fix is prepared. The FDA classified the…
    fda medwatch · 13d agoCRLNegative↗ source
  • Molecular Partners to cut up to 44% of staff as it shifts focus to radiotherapy pipeline
    Molecular Partners announced it will lay off up to 44% of its workforce, affecting as many as 55 positions, as the Swiss biotech redirects its limited cash toward a radiotherapeutic program. The c…
    Fierce Biotech · 13d agoLayoffsNegative↗ source
  • FDA rolls out new inspection coordination plan, lifts estradiol patch warning and HHS permits compounding of six peptides
    FDA's drug center and inspections office have agreed on a new concept of operations (ConOps) to better coordinate inspections and compliance activities. A U.S. senator introduced draft legislation…
    raps · 13d agoRegulatoryNeutral↗ source
  • AstraZeneca drops two early-phase prostate cancer programs
    AstraZeneca announced it is terminating development of two early-phase prostate cancer candidates, AZD9750 and AZD8359, as part of a quarterly pipeline review. AZD9750, an oral androgen-receptor d…
    Fierce Biotech · 13d agoNegative↗ source