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467 stories matching this filter · ← front page

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  • Otsuka and Ionis report ALS drug ulefnersen meets primary endpoint in phase 3 trial
    Otsuka and Ionis have completed the Fusion phase 3 trial of ulefnersen, an RNA‑targeted therapy for ALS patients with mutations in the FUS gene. The study enrolled 89 participants, with 73 forming…
    Fierce Biotech · 6h agoPositive readoutPositive↗ source
  • Iambic Therapeutics eyes IPO as it pushes HER2 inhibitor IAM1363 into early trials
    Iambic Therapeutics, a San Diego AI‑driven biotech, said it is preparing for an initial public offering after securing several large‑scale partnerships with major pharmaceutical companies. In its…
    Fierce Biotech · 12h agoPositive↗ source
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Infectious Disease468
  • Integrative Oncology Proven to Ease Cancer Symptoms, Yet Insurance Still Refuses Coverage
    Professor Lorenzo Cohen, a distinguished integrative oncology researcher and melanoma survivor, argues that the science supporting symptom-relieving therapies for cancer patients is well establishe…
    STAT · 7h agoNegative↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 3h agoLayoffsNegative↗ source
  • Telix to acquire ITM Isotope Technologies for $1.65 billion, adding late-stage radiopharma asset ITM-11
    Telix Pharmaceuticals announced it will purchase Germany‑based ITM Isotope Technologies Munich for $1.65 billion in cash. The agreement also provides for up to $700 million in milestone payments l…
    BioSpace · 1d agoDealPositive↗ source
  • Telix to acquire ITM Isotope for $1.65 billion, targeting radioligand therapy market
    Telix Pharmaceuticals announced it will acquire ITM Isotope Technologies Munich for $1.65 billion upfront, securing a radiopharmaceutical supply network. The acquisition brings an R&D pipeline cen…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Experts see Replimune’s Tudriqev approval as a step toward broader use of localized cancer therapies
    Replimune received FDA approval last month for Tudriqev, an oncolytic virus injected directly into melanoma tumors, marking only the second such approval for a therapy delivered straight into a tum…
    BioSpace · 1d agoApprovalPositive↗ source
  • Walgreens Specialty Pharmacy highlights holistic support to boost oncology medication adherence
    Advances in oncology are moving care out of the clinic and into patients' homes, with treatments becoming more personalized. This shift means patients often manage complex drug schedules themselves…
    BioPharma Dive · 1d agoPositive↗ source
  • CooperSurgical issues recall of INCA infant nasal CPAP sets over loose connection risk
    CooperSurgical has announced a recall of its INCA infant nasal CPAP complete and replacement sets. The recall is due to a potential loose connection between the flexible tubing and the nasal cannu…
    fda medwatch · 1d agoCRLNegative↗ source
  • FDA clears Aptitude’s latest Metrix molecular dx to test for COVID
    The FDA granted Aptitude its first 510(k) clearance for the next-generation Metrix COVID diagnostic that features three-times greater sensitivity with 30% faster results that its original emergency…
    Fierce Biotech · 4d agoApprovalPositive↗ source
  • China unveils five-year plan to grow biotech sector from $3M to $522B by 2030
    China's Ministry of Industry and Information Technology released a new five-year biotech plan that sets out ambitious growth targets for the sector. The plan aims to expand the industry from rough…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Roche opens new research center in Boston, expanding its local presence
    Roche announced the opening of a new research facility in Boston, adding to its existing operations in the city. The center will focus on early-stage drug discovery and will house several hundred…
    STAT · 4d agoPositive↗ source
  • Par Health recalls two lots of dexmedetomidine infusion due to particulate contamination
    Par Health announced a voluntary recall of two lots of its dexmedetomidine HCl in 0.9% sodium chloride injection, which is used for intravenous sedation. The recall was initiated after testing ide…
    fda recalls · 3d agoCRLNegative↗ source
  • GSK adds two China cancer-therapy licensing deals, keeping pace with industry partnership surge
    BioPharma Dive's new visualization series recapped recent activity, spotlighting GSK's licensing agreements in China and the market response. Since the start of 2025, GSK has signed five deals wit…
    BioPharma Dive · 4d agoDealNeutral↗ source
  • FDA updates instructions for NOxBOXi nitric oxide delivery system after leak risk identified
    The FDA has issued a correction for the NOxBOXi nitric oxide delivery system with the NOxMixer module after discovering that the device can leak oxygen during inhaled nitric oxide therapy. The age…
    fda medwatch · 4d agoCRLNeutral↗ source
  • Panel discusses how questions about health equity shape public trust in science
    Anil Oza reported that he participated in a National Academies of Science roundtable focused on population health and how research communication influences public trust. The discussion highlighted…
    STAT · 4d agoNeutral↗ source
  • Roche commits up to $1 billion to develop bispecific antibodies with Dualitas
    Roche announced a partnership with Dualitas Therapeutics, a California biotech, to advance bispecific antibody programs aimed at immunological and inflammatory diseases. The agreement includes an…
    BioSpace · 5d agoDealPositive↗ source
  • Rare inherited EGFR mutation raises lung cancer risk 62-fold in never-smokers, 25-fold in smokers
    Researchers examined genotyping data from 23andMe covering 3.37 million individuals and found the T790M germline mutation in about one out of every 15,850 people. The study reported that carriers…
    Fierce Biotech · 5d agoNeutral↗ source
  • Rare genetic variant linked to much higher lung cancer risk in never-smokers
    Researchers have discovered a very rare genetic variant that dramatically increases the odds of developing lung cancer among people who have never smoked. The study, published in Science, reports a…
    STAT · 4d agoPositive↗ source
  • Novo signs $1.4 billion deal with Orbis Medicines to develop oral macrocycle cardiometabolic drugs
    Novo, which recently rebranded from Novo Nordisk, announced a partnership with Copenhagen‑based Orbis Medicines. The agreement could provide up to $1.4 billion in upfront payments and milestone pay…
    Fierce Biotech · 6d agoDealPositive↗ source
  • FDA holds psychedelic forum as Definium reports third successful Phase 3 trial of oral LSD for anxiety
    The FDA convened a public forum on Monday to discuss the near‑term outlook for psychedelic drug development, highlighting interest from companies such as Compass Pathways and Definium Therapeutics.…
    BioSpace · 6d agoPositive readoutPositive↗ source
  • Novartis stops ALS TREM2 stabilizer after Phase 2 miss, marking fourth trial setback in a month
    Novartis has halted development of its TREM2 stabilizer VHB937, also known as lifonebart, for amyotrophic lateral sclerosis after the drug failed to meet either the primary or secondary endpoints i…
    BioSpace · 6d agoNegative readoutNegative↗ source
  • Sen. Warren calls for release of Trump-era pharma pricing contracts amid accusations against RFK Jr.
    Sen. Warren has publicly demanded that the contracts governing drug pricing under the Trump administration be disclosed. She alleges that RFK Jr. is concealing these agreements, raising concerns ab…
    STAT · 6d agoRegulatoryNeutral↗ source
  • Vera Therapeutics' Trutakna shows kidney function stabilization and lower death risk in Phase 3 IgAN trial
    Vera Therapeutics reported that its drug Trutakna met its primary goals in a two‑year Phase 3 study of patients with IgA nephropathy. The therapy stabilized kidney function and lowered the risk of…
    STAT · 7d agoPositive readoutPositive↗ source
  • New antibody-drug conjugates show promise as potential standard for extensive-stage small cell lung cancer at WCLC 2026
    The World Conference on Lung Cancer showcased several late‑stage trial updates, with a focus on new therapies for small cell lung cancer, the more aggressive form of the disease. Antibody‑drug con…
    BioPharma Dive · 6d agoPositive readoutPositive↗ source