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1,236 stories matching this filter · ← front page

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  • 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 · 2mo 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 · 2mo agoRegulatoryNegative
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  • Massachusetts biotech sees record-first-half VC funding and IPO surge despite modest NIH funding dip
    The latest MassBio Industry Snapshot reports a strong start to 2026 for the state’s biotech sector, with venture capital inflows rising 25% year over year to $3.45 billion in the first half of the…
    Fierce Biotech · 2mo agoPositive↗ 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 · 2mo 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 · 2mo 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 · 2mo agoRegulatoryPositive↗ source
  • Vitruvias Therapeutics recalls one lot of 30 mg thyroid tablets over super potency risk
    Vitruvias Therapeutics announced a voluntary recall of a single lot (Lot No. 504950) of its 30 mg thyroid tablets to the consumer level. Testing confirmed the tablets could be superpotent, raising…
    fda medwatch · 2mo agoCRLNegative↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo agoRegulatoryNeutral↗ source
  • Texas lawmaker warns Chinese biotech firms gaining early-stage advantage over U.S. industry
    Rep. Nathaniel Moran, a Republican from Texas and member of the House Select Committee on China, told Fierce that the United States is overlooking how Chinese biotech companies are outpacing Americ…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Takeda wins FDA nod for orexin drug oveporexton, first treatment for narcolepsy type 1 and potential broader uses
    Takeda received FDA approval for oveporexton (brand Orzeyful), an orexin receptor agonist, marking the first approved therapy that targets the orexin system for narcolepsy type 1. The drug mimics…
    Fierce Biotech · 2mo agoApprovalPositive↗ source
  • Ambros Therapeutics merges with Werewolf, raises $150M to fund phase 3 trial of rare disease drug
    Ambros Therapeutics announced an all‑stock reverse merger with Werewolf Therapeutics, accompanied by a $150 million private placement. The transaction will see the combined company operate under th…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • FDA issues early alert on Medical Action epidural kits containing recalled sodium chloride ampules
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert warning about certain epidural kits from Medical Action Industries. The alert notes that the kits include sodium chlor…
    fda medwatch · 2mo agoRegulatoryNegative↗ source
  • FDA alerts recall of Medline neonatal heated wire breathing circuits over connector failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert to warn the public about a high‑risk issue with Medline's neonatal and infant heated wire breathing circuits. The problem…
    fda medwatch · 2mo agoCRLNegative↗ source
  • Early Alert: Portrait Core Services Software Issue from GE HealthCare
    Patients monitored on Portrait Mobile devices can be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software.
    fda medwatch · 2mo agoRegulatoryNeutral↗ source
  • Moderna's cancer vaccine boost lifts stock, sparks talk of Keytruda-like reach
    Moderna’s shares surged 177% after a phase 3 topline win for its Merck‑partnered cancer vaccine, intismeran autogene, was disclosed. The data, released on Wednesday, added roughly $45 billion to Mo…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 2mo agoApprovalPositive↗ source
  • Trump nominates Heidi Overton as FDA Commissioner as agency releases CGT Q&A guidance
    The U.S. Food and Drug Administration issued final guidance that answers common questions about developing cellular and gene therapy products. The document aims to clarify regulatory expectations f…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Medigen partners with Charles River to advance multivalent enterovirus vaccine globally
    Charles River Laboratories and Taiwan's Medigen Vaccine Biologics announced a collaboration to prepare Medigen’s multivalent enterovirus vaccine for worldwide use. The partnership will focus on ch…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Chai Discovery partners with Bristol Myers Squibb to use AI for antibody discovery
    Chai Discovery, an AI-driven drug discovery company, announced a collaboration with Bristol Myers Squibb to apply its artificial-intelligence models to therapeutic antibody research. The partnershi…
    Fierce Biotech · 2mo agoDealPositive↗ source