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  • FDA approves Eli Lilly's once-weekly insulin pen, setting up rivalry with Novo
    Eli Lilly’s once-weekly basal insulin shot Onswik has been approved by the FDA for patients with type 2 diabetes. Lilly has touted Onswik as a longer-acting alternative to daily basal insulin injec…
    Endpoints · 1mo ago↗ source
  • FDA panel questions effectiveness of Grail's early-cancer detection test
    FDA's Molecular and Clinical Genetics Panel and agency officials raised concerns about Grail's next-generation sequencing test designed to detect multiple cancers early in adults over 50. The advi…
    Endpoints · 1mo agoRegulatoryNegative↗ source
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World's first personalized gene-editing therapy costs $1.65 million per patient, project director says
At a rare disease conference in Oxford, Fyodor Urnov disclosed that the world's first therapy designed to correct an individual’s unique genetic mutation cost $1.65 million to produce. The treatme…
Endpoints · 1mo agoNeutral↗ source
  • Former Changsheng biotech chair sentenced to life in prison over Chinese rabies vaccine scandal
    Chinese authorities sentenced Gao Junfang, the former chairwoman of Changsheng Biotechnology, to life imprisonment after a court found her guilty of wrongdoing in a rabies vaccine scandal. The cas…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Enveda secures $311 million in third consecutive megaround to advance discovery and weight-maintenance programs
    Enveda, a biotech startup operating out of Colorado and India, announced a new financing round on September 23, 2026. The company raised $311 million, marking its third large-scale funding round i…
    Endpoints · 1mo agoDealPositive↗ source
  • AI startup Basecamp Research secures $140 million Series C funding and outlines six-program AI pipeline
    Basecamp Research, an AI-driven biotech founded in 2019, announced a $140 million Series C financing round. The company said the new capital will support its ambitious six-program pipeline that ap…
    Endpoints · 1mo agoDealPositive↗ source
  • Roche reports positive interim Phase 3 results for kidney drug, paving way for accelerated approval
    Roche announced interim results from its Phase 3 trial of a kidney disease therapy, indicating the study met its primary endpoints. The data, released on Wednesday, suggest the drug could qualify…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Roivant's FcRn drug IMVT-1402 fails Phase 2b lupus trial
    Roivant announced that its FcRn-targeting antibody IMVT-1402 (imeroprubart) failed to meet primary endpoints in a Phase 2b trial in patients with lupus. The study did not show improvement in disea…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Family’s struggle to receive cystic fibrosis medication highlights care gaps
    Stephanie Marquart in Knoxville, Tennessee, waited anxiously for a delivery to her home, refreshing the tracking page repeatedly as the package made its way to her doorstep. The episode, described…
    Endpoints · 1mo agoNegative↗ source
  • Industry groups back FDA’s proposed distributed manufacturing rule, seek clarification on implementation
    Industry trade groups have expressed overall support for the FDA’s draft rule that would allow drugs to be produced using distributed manufacturing models. The proposal aims to modernize the supply…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Federal Court Issues Consent Decree Halting Gold Star Distribution's FDA-Regulated Shipments Over Unsanitary Warehouse
    The U.S. District Court for the District of Minnesota entered a consent decree on Sept. 21, 2026 that permanently enjoins Gold Star Distribution, Inc. and its owner Bassam Abu Samrah from distribut…
    fda press · 1mo agoRegulatoryNegative↗ source
  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Amgen reports positive Phase 3 results for Sjögren's drug; Novartis announces $900M radioligand partnership
    Amgen said its CD40 ligand antagonist dazodalibep met the primary endpoint in a Phase 3 trial for Sjögren's syndrome, marking a notable achievement for the company. Novartis disclosed a $900 milli…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Consumer groups call on FDA to strengthen generic drug testing and safety reporting under GDUFA IV
    Consumer health organizations used a public meeting on the reauthorization of the Generic Drug User Fee Amendments to press the FDA for more resources dedicated to testing generic medicines. The g…
    raps · 1mo agoRegulatoryNegative↗ source
  • US officials launch probe into falling German drug prices amid EU pharma push for competitiveness
    US trade officials held a hearing on Tuesday about a possible investigation into the decline in Germany's payments for pharmaceuticals. Testimony presented arguments both supporting and opposing t…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Vertex reports early kidney drug data, boosting hopes for broad label ahead of next year's pivotal readout
    Vertex Pharmaceuticals disclosed early data from its experimental kidney disease therapy inaxaplin, showing improvements on a urine-based biomarker. The drug demonstrated positive changes in two s…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Celldex's barzolvolimab meets Phase 3 goals but safety concerns emerge
    Celldex announced that its experimental chronic hives treatment, barzolvolimab, achieved the primary endpoint in two Phase 3 trials. The trials demonstrated the drug's efficacy in reducing hive sy…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Nvidia-backed Iambic Therapeutics files for IPO, unveils AI-driven pipeline
    Iambic Therapeutics, a San Diego biotech that uses artificial intelligence to discover medicines, announced it has filed a registration statement to become a publicly traded company. The filing ma…
    Endpoints · 1mo agoDealNeutral↗ source
  • Roche presents positive Phase 2 results for enicepatide in overweight and obese type 2 diabetes patients
    Roche has released new data from a Phase 2 trial of enicepatide, a peptide acquired from Carmot Therapeutics, focusing on overweight or obese adults with type 2 diabetes. The trial met its primary…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • FDA issues third warning letter to Empower Pharmacy over GLP-1 weight-loss treatments
    The U.S. Food and Drug Administration sent a formal warning letter to Empower Pharmacy, a compounder based in Houston, concerning its GLP-1 weight-loss products. The notice marks the company's thi…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Federal AI Initiative Aims to Improve Chronic Heart Failure Care, Pending Doctor and Patient Acceptance
    A new federal program will test artificial‑intelligence tools in the management of chronic heart‑failure patients. The initiative is designed to explore how AI can support diagnosis, monitoring and…
    Endpoints · 1mo agoNeutral↗ source
  • Novo CEO acknowledges need to rebuild investor confidence after muted capital markets day
    Novo held a capital markets day on Monday in London, where the company outlined its strategy. Investors said the presentation left them underwhelmed. CEO Mike Doustdar acknowledged the reaction, s…
    Endpoints · 1mo agoNegative↗ source
  • Regulators Share Guidance for Effective Sponsor Meetings
    Regulators from the U.S. FDA, the U.K. MHRA and other European agencies met to outline best practices for sponsor‑regulator interactions. They highlighted that transparency, open collaboration, at…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Global regulators must align on new approach methodologies to give sponsors certainty
    New approach methodologies, or NAMs, are being promoted as ways to reduce reliance on animal testing in drug development. They promise faster, more humane studies while still providing safety data.…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Pharma firms ask Trump admin to safeguard China partnerships as EU pushes for quicker trials and higher spending
    Pharma companies in the United States are urging the Trump administration to take steps that would protect their existing and future business arrangements with Chinese partners. At the same time,…
    raps · 1mo agoRegulatoryNeutral↗ source