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763 stories matching this filter · ← front page

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  • Novartis and Bristol Myers pause autoimmune CAR-T trials after serious safety events
    Novartis and Bristol Myers Squibb announced the suspension of several autoimmune CAR‑T studies after encountering serious safety problems. In Novartis' trials, three participants died from a severe…
    BioPharma Dive · 9d agoNegative readoutNegative↗ source
  • UniQure files FDA priority review request for Huntington’s gene therapy AMT-130
    UniQure, a Dutch biotech, announced on Wednesday that it has submitted applications to the U.S. Food and Drug Administration seeking a priority review for its gene therapy AMT-130, which targets th…
    BioPharma Dive · 9d agoRegulatoryNeutral↗ source
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Infectious Disease456
  • Medline expands recall of reprocessed electrophysiology and ultrasound catheters due to contamination risk
    Medline Industries has issued an expanded recall that adds new lots of reprocessed electrophysiology and ultrasound catheters after the FDA identified possible residual particulates in the devices.…
    fda medwatch · 10d agoCRLNegative↗ source
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 9d agoPositive readoutPositive↗ source
  • EMA starts voluntary data-sharing pilot to boost confidence in new approach methods and cut animal testing
    The European Medicines Agency announced a voluntary data submission pilot that allows drug developers to upload data generated by new approach methodologies (NAMs). The pilot is designed to build…
    raps · 10d agoRegulatoryPositive↗ source
  • FDA alerts AVID Medical users to correct convenience kits containing recalled sodium chloride ampules
    The Center for Devices and Radiological Health has posted an Early Alert warning that certain AVID Medical convenience kits may contain sodium chloride ampules recalled by Huons Co. AVID Medical h…
    fda medwatch · 10d agoRegulatoryNeutral↗ source
  • Medline issues correction for convenience kits with potentially non-sterile BD ChloraPrep applicators
    Medline has sent a correction notice after the FDA identified that some BD ChloraPrep applicators included in its convenience kits may not be sterile. The agency says the devices could cause tempo…
    fda medwatch · 10d agoCRLNeutral↗ source
  • Frutas y Hortalizas del Sur expands recall to include Great Value organic triple berry blend over possible E. coli O145 contamination
    On September 2, 2026, Frutas y Hortalizas del Sur S.A. announced that it is expanding the recall it issued on July 3, 2026 for frozen organic IQF blueberries. The expansion adds one lot of Great V…
    fda recalls · 9d agoCRLNegative↗ source
  • Alumis' TYK2 inhibitor flunks mid-stage lupus trial, shares drop 55%
    Alumis reported that its experimental TYK2 inhibitor, envudeucitinib, failed to meet any primary or secondary endpoints in a mid-stage study of systemic lupus erythematosus. The company highlighte…
    BioPharma Dive · 10d agoNegative readoutNegative↗ source
  • Novartis reports Phase 3 success for MS pill remibrutinib, beats Aubagio and shows no liver safety issues
    Novartis announced that its BTK inhibitor remibrutinib met primary endpoints in two Phase 3 trials in patients with relapsing multiple sclerosis. The studies showed the drug reduced annualized rel…
    BioPharma Dive · 10d agoPositive readoutPositive↗ source
  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 11d agoRegulatoryNeutral↗ source
  • FDA urges validation of digital health endpoints and clear missing-data plans
    FDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…
    raps · 11d agoRegulatoryNeutral↗ source
  • Trump unveils pricing agreements with midsize biotech firms; Novartis halts CAR-T trial after patient deaths
    The White House announced that President Trump has struck new pricing agreements with a group of midsize biotechnology companies, aiming to adjust drug costs. Novartis disclosed that it is pausing…
    raps · 11d agoDealNeutral↗ source
  • Mid-size biotechs join White House Medicaid pricing program, gain tariff relief
    Nine mid-size drugmakers announced they will take part in the White House’s GENEROUS Medicaid pricing model, which ties U.S. Medicaid payments to the lowest prices paid abroad. In return, the comp…
    BioPharma Dive · 10d agoRegulatoryNeutral↗ source
  • Medline recalls neonatal and infant heated wire breathing circuits over connector failures
    Medline has issued a recall for specific neonatal and infant heated wire breathing circuits after identifying failures in the electrical connector. The FDA has classified the issue as potentially…
    fda medwatch · 11d agoCRLNegative↗ source
  • FDA clears Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera, opening potential $2 billion market
    The Food and Drug Administration has granted clearance to rusfertide, sold under the brand name Mimrylo, for the treatment of polycythemia vera, a rare blood disorder that causes excess red blood c…
    BioPharma Dive · 11d agoApprovalPositive↗ source
  • Eli Lilly to acquire Merida Biosciences in near-$2.9 billion deal to expand immune-disease pipeline
    Eli Lilly announced it will buy privately held Merida Biosciences, a company that has created a technology to target and break down malfunctioning antibodies that drive many autoimmune disorders.…
    BioPharma Dive · 11d agoDealPositive↗ source
  • FDA clears Protagonist-Takeda therapy for rare blood cancer as Lilly moves to buy Merida for up to $2.88 billion
    The U.S. Food and Drug Administration has granted approval to a collaborative therapy from Protagonist and Takeda aimed at treating a rare form of blood cancer. This regulatory decision adds a new…
    raps · 12d agoDealPositive↗ source
  • Cytokinetics reports Phase 3 success for Myqorzo but shares tumble as investors weigh market impact
    At the European Society of Cardiology meeting, Cytokinetics presented Phase 3 data for Myqorzo in non‑obstructive hypertrophic cardiomyopathy, showing benefit in both forms of the disease and disti…
    BioPharma Dive · 11d agoPositive readoutNeutral↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after safety concerns
    Novartis announced a temporary hold on its personalized CAR-T therapy rap-cel after three patients experienced immune effector cell-associated hemophagocytic syndrome, a rare and potentially life-t…
    BioPharma Dive · 11d agoRegulatoryNegative↗ source
  • Verily, NVIDIA and NIH launch first multimodal AI model combining EHR and genomics
    Verily Health, in partnership with NVIDIA and the NIH All of Us Research Program, announced the development of a new foundation model that merges electronic health record data with genomic informat…
    BioPharma Dive · 12d agoPositive↗ source
  • Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance
    A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders. Indu…
    raps · 12d agoRegulatoryNeutral↗ source
  • Crystal Temptations Issues Allergy Alert on Undeclared Milk in Chocolatey Eyeballs
    Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run th…
    fda recalls · 11d agoRegulatoryNeutral↗ source
  • Industry and patient groups urge FDA to revise master protocol guidance
    Industry groups and patient advocacy organizations have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for…
    raps · 12d agoRegulatoryNeutral↗ source
  • India streamlines regulations for outsourced medical device sterilization
    The Indian government announced a simplification of the regulatory framework governing outsourced sterilization of medical devices. The move is part of a broader effort to make it easier for busine…
    raps · 12d agoRegulatoryPositive↗ source