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1,814 stories matching this filter · ← front page

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  • Zocdoc pushes AI personal agents into healthcare as other sectors restrict their use
    Zocdoc is positioning AI personal agents to take on patient‑focused tasks, signaling a new direction for health‑tech services. While Amazon, Delta Air Lines and several major U.S. banks have block…
    Endpoints · 11d agoPositive↗ source
  • Survey finds 78% of scientists expect AI to accelerate drug discovery this year
    Endpoints Signal surveyed roughly 1,500 biopharma insiders about AI's near-term impact on drug discovery. The respondents included a broad mix of industry roles. While scientists had been the most…
    Endpoints · 11d agoPositive↗ source
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Astellas secures exclusive option on Audax Biosciences preclinical IL-12 cancer drug
Astellas has taken an exclusive option to license a preclinical immuno-oncology asset from Audax Biosciences, an Australian biotech company. The asset is an IL-12 based cancer therapeutic that is…
Endpoints · 12d agoDealNeutral↗ source
  • FDA issues draft guidance for electronic IDE submissions via eSTAR
    The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
    raps · 12d agoRegulatoryNeutral↗ source
  • HHS pauses enforcement of ban on compounding wellness peptides as FDA drafts new rules
    HHS announced it will temporarily stop enforcing the existing prohibition on the compounding of certain peptides marketed for wellness. The agency said the move is intended to protect consumer saf…
    Endpoints · 11d agoRegulatoryNeutral↗ source
  • Lilly's triple-G drug retatrutide outshines Novo's Ozempic in diabetes
    Eli Lilly’s retatrutide, the incretin shot that has already proven its effectiveness against other assets on a cross-trial basis, has cemented its utility in a head-to-head trial, albeit in diabete…
    Endpoints · 12d ago↗ source
  • Novartis reaffirms $12 billion Avidity acquisition despite $1.9 billion impairment loss
    Novartis said its $12 billion purchase of Avidity Biosciences remains on track, according to CEO Vas Narasimhan. The comment followed the company's disclosure of a $1.9 billion impairment charge t…
    Endpoints · 13d agoDealNeutral↗ source
  • US Treasury draft COINS rules could sharply limit China biotech partnerships
    US Treasury released a draft set of regulations known as the COINS rule that targets cross-border biotech transactions. The proposal would bar certain US-China deals and tighten oversight of collab…
    Endpoints · 12d agoRegulatoryNegative↗ source
  • Ferring agrees to buy fertility startup Gameto in deal up to $1.38 billion
    Ferring Pharmaceuticals announced it has signed an agreement to acquire Gameto, a biotech company developing an ovary-in-a-dish platform for fertility treatments. The transaction is structured as…
    Endpoints · 12d agoDealNeutral↗ source
  • 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 · 13d 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 · 13d agoRegulatoryNeutral↗ source
  • 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 · 12d 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 · 12d 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 · 12d agoNeutral↗ 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 · 13d 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 · 12d 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 · 12d 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 · 12d 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 · 12d 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 · 13d agoRegulatoryNeutral↗ 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 · 13d 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 · 13d 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 · 13d 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 · 14d 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 · 14d agoApprovalNeutral↗ source