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  • Curium seeks FDA review of rival radioligand therapy to boost supply resilience against Novartis' Pluvicto
    Curium is preparing to challenge Novartis' dominant prostate cancer radioligand therapy, Pluvicto, by entering discussions with the FDA about reviewing its own PSMA‑directed Lu‑177 candidate. Nova…
    BioSpace · 2h agoRegulatoryNeutral↗ source
  • Roche's Genentech signs up to $2.3B deal with Hanmi for weight-loss drug that preserves lean mass
    Roche, through its Genentech subsidiary, has entered a licensing agreement with South Korea's Hanmi Pharm that could be worth up to $2.3 billion, including a $190 million upfront payment. The deal…
    BioSpace · 17h agoDealPositive↗ source
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  • Roche and Eli Lilly receive FDA clearance for first blood test detecting Alzheimer’s biomarker pTau217
    Roche and Eli Lilly have secured FDA clearance for a new blood test that measures phosphorylated tau protein pTau217, a marker linked to amyloid plaques in Alzheimer’s disease. The Elecsys pTau217…
    Fierce Biotech · 23h agoApprovalPositive↗ source
  • Roche signs $2.5 billion deal with Hanmi for experimental obesity drug targeting muscle loss
    Roche's Genentech unit has agreed to acquire global rights (outside South Korea) to Hanmi's clinical-stage urocortin-2 analog, HM17321, as part of a deal valued up to $2.5 billion. The agreement i…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Moderna and Merck report promising results from cancer vaccine amid early skepticism
    Moderna and Merck say their experimental mRNA cancer vaccine has produced encouraging mid‑stage data, shifting the narrative from doubt to optimism. At a March 2023 leadership meeting, executives…
    STAT · 22h agoPositive readoutPositive↗ source
  • FDA places hold on REGENXBIO's Hunter syndrome gene therapy after spinal nodules found, company pauses resubmission
    The FDA placed a clinical hold on RGX-121, REGENXBIO's gene therapy for Hunter syndrome, after MRI scans showed small nodules or cystic masses in the spines of five trial participants. The finding…
    BioSpace · 17h agoRegulatoryNegative↗ source
  • FDA places clinical hold on Regenxbio’s RGX-121 gene therapy after spine MRI findings, delaying refiling plans
    The U.S. Food and Drug Administration has issued a clinical hold on Regenxbio’s gene therapy candidate RGX-121 after routine MRI scans revealed asymptomatic changes in the spines of trial participa…
    Fierce Biotech · 22h agoRegulatoryNegative↗ source
  • FDA alerts users to destroy AVID Medical IV start kits containing recalled BD ChloraPrep applicators due to fungal contamination risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert warning that certain AVID Medical convenience kits may pose a high‑risk fungal contamination problem because they contain…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • FDA grants three-month extension for Capricor’s Duchenne therapy deramiocel, sets new action date Nov 22
    The U.S. Food and Drug Administration has given Capricor Therapeutics a three‑month extension to review additional data for its Duchenne muscular dystrophy cell therapy, deramiocel. The agency has…
    BioSpace · 15h agoRegulatoryNeutral↗ source
  • Lady Gaga and fiancé announce new biotech startup as FTC eyes Amgen patents and Moderna-Merck vaccine advances
    Lady Gaga and her fiancé have announced the formation of a new biotech startup, marking a rare foray of a pop culture figure into the life‑science sector. The Federal Trade Commission has begun a…
    STAT · 15h agoNeutral↗ source
  • FDA pauses Regenxbio gene therapy trial for Hunter syndrome after spinal masses found
    The Food and Drug Administration has placed another hold on Regenxbio's gene-therapy trial for mucopolysaccharidosis type II, also known as Hunter syndrome, after new safety concerns emerged. Five…
    STAT · 18h agoRegulatoryNegative↗ source
  • Qiagen names Jonathan M. Pratt as new chief executive after nine-month search
    Qiagen announced that Jonathan M. Pratt will take over as chief executive, ending a nine‑month search for a successor. Pratt arrives from Filtration Group, where he served as president and CEO. He…
    Fierce Biotech · 20h agoNeutral↗ source
  • TME Pharma narrows licensing talks for brain-cancer drug NOX-A12, eyes $1 billion market
    TME Pharma, a German biotech, says it has narrowed potential partners for its experimental glioblastoma therapy NOX-A12, a CCL2 inhibitor, to two firms and entered a final evaluation phase. The co…
    Fierce Biotech · 20h agoDealNeutral↗ source
  • Spruce Biosciences advances toward Q4 FDA filing for ultra-rare Sanfilippo B therapy
    Spruce Biosciences reported progress toward filing its enzyme replacement therapy, tralesinidase alfa (TA-ERT), for Sanfilippo syndrome type B, an ultra-rare lysosomal disorder. The company said t…
    Fierce Biotech · 20h agoRegulatoryPositive↗ source
  • FDA to Issue Formal Guidance on Regulating Generative AI Medical Devices
    The Food and Drug Administration announced that it is creating a plan to regulate medical devices that incorporate generative artificial intelligence. Rick Abramson, director of the agency’s Digita…
    STAT · 22h agoRegulatoryPositive↗ source
  • Trump administration rule bars Medicaid payment for pediatric gender-affirming meds, could set broader coverage precedent
    The Centers for Medicare & Medicaid Services released a final rule that prohibits the use of federal Medicaid and CHIP funds for pediatric gender-affirming medications and related surgeries. The ru…
    STAT · 22h agoRegulatoryNegative↗ source
  • FDA’s new leadership aims to restore reliability, but each application remains judged on its data
    The FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary. Recent actio…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • FDA issues early alert on CooperSurgical infant nasal CPAP devices with loose tubing connection
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert about a potential high-risk issue with certain CooperSurgical infant nasal CPAP devices. The problem involves a loose…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • FDA alerts to potential fungal contamination in Medline kits containing recalled BD ChloraPrep applicators
    The Center for Devices and Radiological Health (CDRH) has issued an Early Alert to warn the public about a possible high-risk device problem involving Medline convenience kits. Medline has sent a…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • FDA clears Roche and Lilly Alzheimer’s blood tests, while Regenxbio gene therapy trial halted again
    The U.S. Food and Drug Administration announced it has granted clearance for blood-based diagnostic tests for Alzheimer’s disease developed by Roche and Eli Lilly. The clearances allow the compani…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA asks industry input on competency-based rules for generative AI medical devices
    The FDA announced it is soliciting comments on a proposed competency-based framework for overseeing medical devices that incorporate generative artificial intelligence. The agency says the approac…
    raps · 1d agoRegulatoryNeutral↗ source
  • Medicaid coverage for GLP-1 weight-loss drugs stalls, only Indiana signs on
    President Trump pledged to broaden Medicaid access to costly GLP-1 obesity medications by letting states negotiate prices directly with manufacturers. The rollout depended on state participation,…
    STAT · 17h agoRegulatoryNegative↗ source
  • FDA signals upcoming rules for generative AI use in drug development
    The FDA announced it intends to create regulatory guidance for the use of generative artificial intelligence in pharmaceutical research and development. The move follows growing interest in AI too…
    STAT · 18h agoRegulatoryNeutral↗ source
  • FDA finalizes guidance on therapeutic equivalence evaluations for ANDAs
    The U.S. Food and Drug Administration has issued final guidance describing its approach to therapeutic equivalence (TE) evaluations and the assignment of TE codes for abbreviated new drug applicati…
    raps · 1d agoRegulatoryNeutral↗ source
  • Aon warns 2027 will bring steep rise in employer health premiums, highlighting data gaps for public-sector plans
    Aon’s chief actuary warned that 2026 data points to a harsh 2027 for employer-sponsored health insurance premiums, with costs expected to rise sharply. The firm said employers will need better dat…
    STAT · 16h agoNegative↗ source