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857 stories matching this filter · ← front page

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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 · 4h agoRegulatoryNeutral↗ source
  • FDA grants Capricor three-month extension to review DMD cell therapy data
    The U.S. Food and Drug Administration has given Capricor Therapeutics an additional three months to evaluate its Duchenne muscular dystrophy cell therapy after the agency asked for more information…
    Fierce Biotech · 5h agoRegulatoryNegative↗ source
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Infectious Disease373
  • Massachusetts biopharma employment slips 3.1% in 2025 as R&D jobs fall, while manufacturing rises
    A new MassBio industry snapshot shows that total biopharma employment in Massachusetts fell 3.1% in 2025, translating to roughly 3,600 fewer jobs compared with the previous year. The decline was m…
    BioSpace · 1h agoNeutral↗ 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 · 19h agoDealPositive↗ source
  • 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 · 1d 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
  • 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 · 19h 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 · 1d 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 · 17h agoRegulatoryNeutral↗ 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 · 22h 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 · 22h 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 · 22h agoRegulatoryPositive↗ 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
  • 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
  • Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
    The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
    fda medwatch · 1d agoRegulatoryNeutral↗ source
  • Health Secretary Kennedy criticizes CDC vaccine classification scheme and shared decision-making category
    Robert F. Kennedy Jr., serving as Health Secretary, has raised concerns about how the CDC categorizes vaccine recommendations. The CDC uses three categories: routine recommendations for universal…
    BioSpace · 20h agoRegulatoryNegative↗ source
  • Australian regulator TGA opens consultation on automated decision making for listed medicine variations
    The Therapeutic Goods Administration has launched a public consultation to gather input on proposed changes that would enable automated decision making for variation applications of listed medicine…
    raps · 1d agoRegulatoryNeutral↗ source
  • Boehringer Ingelheim pauses Phase 1 study of oral candidate BI 3031185 after safety event
    Boehringer Ingelheim has placed a Phase 1 study of its oral candidate BI 3031185 on hold after a safety event was identified. The trial, run in Japan with healthy volunteers, was assessing tolerab…
    BioSpace · 21h agoCRLNegative↗ source
  • Everything Sprouts recalls alfalfa sprouts over possible E. coli and Salmonella contamination
    Everything Sprouts, LLC, a Minneapolis‑based producer, announced a recall of certain lots of its alfalfa sprouts on August 22, 2026. The recall was triggered because the sprouts may be contaminate…
    fda recalls · 3d agoCRLNegative↗ source
  • US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deaths
    Three recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…
    BioSpace · 3d agoRegulatoryNegative↗ source