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841 stories matching this filter · ← front page

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  • 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 · 19d 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 · 19d agoRegulatoryPositive↗ source
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Psychiatry & CNS882
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Infectious Disease456
  • Pharma marketers urged to adopt share-of-answer strategy as AI use surges among physicians
    Pharma marketers are planning for 2027 as artificial intelligence reshapes how clinicians seek clinical answers. The rise of AI tools means that traditional metrics like share of voice and broad om…
    BioPharma Dive · 19d agoNeutral↗ 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 · 19d 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 · 19d 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 · 19d 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 · 19d 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 · 19d agoRegulatoryNeutral↗ source
  • Cellares to cut 100 jobs after losing contract with unnamed large pharma customer
    Cellares, a cell therapy manufacturing startup based in South San Francisco, announced it will lay off about 100 employees. The cuts follow the termination of a contract by an unnamed large pharma…
    BioPharma Dive · 18d agoLayoffsNegative↗ 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 · 19d 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 · 19d 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 · 19d agoRegulatoryNeutral↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 18d agoNeutral↗ 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 · 19d agoNeutral↗ source
  • Lilly leads GLP-1 weight-loss market while Novo Nordisk’s Wegovy exceeds expectations but falls short of forecasts
    Eli Lilly and Novo Nordisk are intensifying their battle for dominance in the multibillion‑dollar GLP‑1 weight‑loss market, with each company promoting its own set of injectable therapies and pipel…
    BioPharma Dive · 21d agoEarningsNeutral↗ 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 · 21d 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 · 22d 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 · 22d agoRegulatoryNegative↗ source
  • Activist Kaos Capital pushes governance overhaul at Capricor ahead of FDA Duchenne decision
    Activist investor Kaos Capital has sent a letter to Capricor Therapeutics shareholders demanding a “governance reset.” The firm asks for a meeting to nominate two independent directors, create an M…
    BioPharma Dive · 21d agoNegative↗ 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 · 22d 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 · 22d agoRegulatoryNeutral↗ source
  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 22d agoPositive readoutPositive↗ 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 · 23d 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 · 23d 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 · 23d agoRegulatoryNeutral↗ source