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2,343 stories matching this filter · ← front page

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  • 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 · 16d 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 · 16d agoNeutral↗ source
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  • 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 · 17d 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 · 17d 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 · 16d 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 · 16d 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 · 16d 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 · 16d 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 · 17d agoRegulatoryNeutral↗ source
  • Ferring to acquire next-gen IVF startup Gameto for up to $1.4B
    The buyout hands Ferring rights to a technology capable of simplifying the lengthy and burdensome process of in vitro fertilization.
    BioPharma Dive · 16d ago↗ source
  • Artiva to quit autoimmune cell therapy work, cut staff after patient deaths
    The disclosure makes Artiva the third company to recently report fatal events in an autoimmune cell therapy trial, following announcements from Novartis and Bristol Myers Squibb.
    BioPharma Dive · 16d ago↗ source
  • Melanoma vaccine shows 42% risk reduction at ESMO 2026, but shares tumble on early data release
    Moderna and Merck presented Phase 3 results for their melanoma vaccine intismeran autogene at the European Society for Medical Oncology meeting. The trial reported a 42% reduction in the relative r…
    BioPharma Dive · 17d agoPositive readoutNeutral↗ 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 · 17d agoNegative↗ source
  • Corxel to go public via $300 million SPAC merger, advancing GLP-1 pill CX11 and amylin candidate
    Corxel Pharmaceuticals announced it will become a public company by merging with the SPAC Amanat Acquisition Corp., accompanied by a $300 million private investment. The transaction will fund the…
    BioPharma Dive · 17d agoDealPositive↗ 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 · 17d 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 · 17d agoNeutral↗ source
  • Patient dies after receiving Bristol Myers experimental autoimmune CAR-T therapy zola-cel
    A participant in Bristol Myers Squibb’s multiple sclerosis trial died 44 days after being infused with the experimental cell therapy known as zola-cel. The company disclosed that the patient develo…
    BioPharma Dive · 17d agoNegative readoutNegative↗ source
  • Overlooked drugs can gain value when markets evolve, says Azurity CEO
    Ron Scarboro, chief executive of Azurity Pharmaceuticals, wrote about how medicines that seemed unsuccessful can become valuable when market conditions change. He argues that the industry often co…
    BioPharma Dive · 18d 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 · 18d 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 · 18d 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 · 17d 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 · 17d 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 · 17d agoNeutral↗ source
  • Manufacturing hurdles grow as next-gen protein therapeutics gain traction
    Cytiva's sponsored piece highlights growing interest in next-generation protein-based drugs such as antibody-drug conjugates, multispecific antibodies, fragments and synthetic peptides. These moda…
    BioPharma Dive · 18d 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 · 17d agoDealNeutral↗ source