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2,003 stories matching this filter · ← front page

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  • Novartis weighs private-pay launches in Europe as MFN rules pressure government pricing
    Novartis CEO Vas Narasimhan said the company is exploring the option of introducing new medicines directly to private or self‑pay patients in Europe. The discussion is driven by the European Union…
    Endpoints · 14d agoRegulatoryNegative↗ source
  • FDA releases draft guidance on oversight of individualized gene-editing products
    The U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…
    raps · 14d agoRegulatoryNeutral↗ source
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  • Artiva Biotherapeutics to cease operations after two deaths in autoimmune cell therapy trials
    Artiva Biotherapeutics announced it will wind down and lay off nearly all staff following two patient fatalities in its autoimmune cell therapy trials. The deaths occurred during clinical testing…
    Endpoints · 14d agoNegative↗ source
  • Biopharma optimism climbs after FDA commissioner Makary's exit, survey finds
    Endpoints Signal released its Q3 Biopharma Sentiment Index, showing the highest level of industry optimism in years, according to a survey of 569 insiders. The index’s regulatory score rose sharpl…
    Endpoints · 14d agoRegulatoryPositive↗ source
  • Gubra aims to expand beyond obesity drugs, targets first portfolio partner this year
    Copenhagen‑based biotech Gubra is currently known for its obesity drug candidates, but the company says its long‑term growth will depend on a broader pipeline beyond metabolism. The firm’s existin…
    Endpoints · 14d agoNeutral↗ source
  • FDA issues early alert on B. Braun Streamline Bloodline Set recall due to connector leak risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert about B. Braun's Streamline Bloodline Set for Dialog+ after discovering a potential high risk issue. The problem is trace…
    fda medwatch · 14d agoCRLNegative↗ source
  • FDA approves prostate cancer and Crohn’s disease therapies as judge rejects effort to block Lilly weight‑loss ads
    The U.S. Food and Drug Administration announced approvals for new treatments targeting prostate cancer and Crohn’s disease. The decisions expand therapeutic options for patients with these conditio…
    raps · 14d agoRegulatoryNeutral↗ source
  • U.S. judge rejects Novo Nordisk's bid to block Eli Lilly obesity drug ads
    A U.S. federal judge denied Novo Nordisk's request to halt television advertisements by Eli Lilly for its obesity treatments. Novo had argued the ads were misleading and sought an injunction, but…
    Endpoints · 14d agoRegulatoryNegative↗ source
  • Anthropic acquires one-person biotech Mithril Medicine to expand into life sciences
    Anthropic, known for its artificial intelligence work, announced it has purchased Mithril Medicine, a drug discovery startup run by a single individual. The deal is presented as a step in Anthropi…
    Endpoints · 13d agoDealNeutral↗ source
  • Mennonite family backs new gene-therapy startup
    A new gene‑therapy company is taking shape with financial support from members of the Amish and Mennonite communities. The story highlights the unusual partnership between a traditional religious g…
    Endpoints · 14d agoDealNeutral↗ source
  • Outpace Bio halts Phase 1 ovarian cancer CAR‑T trial
    Outpace Bio announced that it has stopped its Phase 1 trial of OPB-101, an autologous CAR‑T therapy targeting mesothelin in ovarian cancer. The company said the trial will no longer enroll patient…
    Endpoints · 14d agoNegative readoutNegative↗ source
  • FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech Conference
    At the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…
    raps · 14d agoRegulatoryNeutral↗ source
  • Taylor Farms recalls H-EB Backyard BBQ Chop Salad Kit over possible undeclared soy and almonds
    Taylor Farms of Dallas, Texas announced a recall of the H-EB Backyard BBQ Chop Salad Kit because the product may contain undeclared soy and tree nuts (almonds). The kits were distributed to H-EB…
    fda recalls · 14d agoCRLNegative↗ source
  • Haifa Smoked Fish recalls 560 lbs of cold-smoked sprats over possible Clostridium botulinum contamination
    Haifa Smoked Fish of Queens, NY announced a recall of about 560 pounds of its cold-smoked sprats after testing indicated possible contamination with Clostridium botulinum, a bacterium that can caus…
    fda recalls · 14d agoRegulatoryNegative↗ source
  • Employers sue UnitedHealth, alleging overpayment of workers' medical claims
    Six major U.S. companies have filed a lawsuit against UnitedHealth Group, claiming the insurer overpaid medical claims for their employees, which they say increased their costs. The plaintiffs inc…
    Endpoints · 15d agoNegative↗ source
  • WuXi AppTec lifts 2026 revenue outlook despite US defense designation dispute
    WuXi AppTec, a leading Chinese contract research and manufacturing organization, announced it has again lifted its revenue forecast for 2026. The company said the upward revision reflects accelera…
    Endpoints · 15d agoNeutral↗ source
  • SystImmune/BMS and Hengrui showcase ADC data for EGFR-mutant lung cancer at ESMO
    At the European Society for Medical Oncology (ESMO) meeting in Madrid, Li Zhang of Sun Yat-sen University Cancer Center presented early data from the HERON‑Lung01 study, highlighting an antibody‑dr…
    Endpoints · 15d agoNeutral↗ source
  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 15d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 15d agoApprovalNeutral↗ source
  • Microsoft AI twice as accurate as doctors in diagnosing cases, study shows
    Microsoft announced that its artificial‑intelligence system achieved roughly double the diagnostic accuracy of physicians in a recent study. The evaluation compared the AI’s performance with that…
    Endpoints · 15d agoPositive readoutPositive↗ source
  • Roche delays European filing of breast-cancer pill giredestrant amid US pricing pressures
    Roche announced it will now seek European approval for its investigational breast cancer oral therapy giredestrant later than previously planned. The delay reflects the impact of U.S. drug pricing…
    Endpoints · 15d agoRegulatoryNeutral↗ source
  • Merck highlights oncology pipeline and cancer vaccine trial at ESMO 2026
    Merck attended the European Society for Medical Oncology (ESMO) meeting in Madrid, using the conference to present updates on its oncology portfolio. Media coverage largely centered on the company…
    Endpoints · 15d agoNeutral↗ source
  • Aspen Neuroscience and Bambusa Therapeutics each aim for $135 million IPOs
    Aspen Neuroscience announced plans to raise about $135 million through an initial public offering, proposing to sell roughly 9.38 million shares. Bambusa Therapeutics also filed for an IPO targeti…
    Endpoints · 15d agoDealNeutral↗ source
  • Corxel Group to go public in US by merging with SPAC, targeting oral GLP-1 market
    Corxel Group announced that it will become a publicly traded company in the United States through a merger with a special purpose acquisition company. The move follows a similar SPAC transaction by…
    Endpoints · 15d agoDealNeutral↗ source
  • Lilly Oncology President Jacob Van Naarden: A Music-Loving Dealmaker With Clear Vision
    Jacob Van Naarden, who now leads Lilly Oncology and heads corporate business development, first gained attention on a Princeton University stage where he performed as a Broadway character during hi…
    Endpoints · 15d agoPositive↗ source