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2,505 stories matching this filter · ← front page

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  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 17d agoRegulatoryNeutral↗ source
  • ESMO 2026: Merck’s Kelun-partnered ADC cuts death risk by over 30% in endometrial cancer
    Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first…
    BioSpace · 16d ago↗ source
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Roche's KRAS G12C inhibitor cuts death risk by 44% versus Amgen and BMS in lung cancer trial
At the European Society for Medical Oncology meeting in Madrid, Roche presented data on its next‑generation KRAS G12C inhibitor in non‑small cell lung cancer. In a head‑to‑head study against compa…
Endpoints · 17d agoPositive readoutPositive↗ source
  • Akeso reports survival benefit for ivonescimab in China-only biliary tract cancer trial, likening results to Keytruda
    Akeso announced new data from a late‑stage study of its PD‑1×VEGF bispecific antibody ivonescimab in patients with biliary tract cancer enrolled only in China. The trial showed an improvement in o…
    Endpoints · 17d agoPositive readoutPositive↗ source
  • Pfizer shifts focus after lung cancer trial setback, cites early signals in earlier-line patients; BioNTech and BMS report initial activity
    Pfizer’s late‑stage trial in non‑small cell lung cancer did not meet its primary endpoint, prompting the company to highlight a post‑hoc analysis that suggests benefit for patients treated earlier…
    Endpoints · 17d agoNeutral↗ source
  • AstraZeneca reports Tagrisso-Orpathys combo could prolong treatment for EGFR-mutant lung cancer
    At the European Society for Medical Oncology meeting, AstraZeneca said early data suggest that adding Orpathys to Tagrisso may let patients with mutant non‑small cell lung cancer continue therapy a…
    Endpoints · 17d agoPositive readoutPositive↗ source
  • #ESMO26: Merck and Moderna's cancer vaccine data were 'a triumph of science.' And now, the work begins
    MADRID — In a testament to clinicians’ interest in Merck and Moderna’s personalized cancer vaccine data at this year’s European Society for Medical Oncology conference, the presidential symposium,…
    Endpoints · 17d ago↗ source
  • Amgen's Imdelltra plus AstraZeneca's Imfinzi cuts death risk by 58% in small cell lung cancer Phase 3 trial
    Amgen reported results from a Phase 3 trial evaluating its investigational therapy Imdelltra in combination with AstraZeneca’s immunotherapy Imfinzi in patients with small cell lung cancer. The st…
    Endpoints · 18d agoPositive readoutPositive↗ source
  • Merck and Moderna present Phase 3 cancer vaccine data at ESMO26 amid Treasury proposal on China investment
    Endpoints Weekly reporter Nicole DeFeudis writes from Madrid during the ESMO26 meeting. The most anticipated presentation was a Phase 3 study of a cancer vaccine jointly developed by Merck and Mod…
    Endpoints · 18d agoNeutral↗ source
  • Tonight We Ride recalls Ultimate Forza male supplement after finding undeclared sildenafil, tadalafil and dapoxetine
    Tonight We Ride, LLC of Lakeville, Minnesota announced a voluntary recall of its Ultimate Forza male supplement capsules. The recall was triggered after testing revealed the product contains undec…
    fda recalls · 18d agoCRLNegative↗ source
  • AstraZeneca, Lilly and Bayer unveil new strategies at ESMO 2026 in Madrid
    At the European Society for Medical Oncology (ESMO) congress in Madrid, nearly 40,000 delegates gathered for the five-day meeting. AstraZeneca said it is evaluating the use of its immunotherapy Ke…
    Endpoints · 18d agoNeutral↗ source
  • Roche warns Germany faces last chance to regain pharma investment confidence
    Roche has said that recent German healthcare reforms threaten the country's attractiveness for pharmaceutical investment. The company paused its own German investment plans after the reforms were a…
    BioSpace · 19d agoRegulatoryNegative↗ source
  • Marengo's bispecific antibody invikafusp alfa shows tumor shrinkage in 8 cancer types in Phase 2
    Marengo Therapeutics presented Phase 2 data for its bispecific antibody invikafusp alfa at the European Society for Medical Oncology meeting in Madrid. The study, part of the Start-001 first‑in‑hum…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • US Treasury proposes rule that could bar biotech investments in China
    The Treasury Department issued a proposed rule to implement the 2025 COINS Act, which governs U.S. investment in sensitive technologies in China and other countries. The proposal places a broad ra…
    Endpoints · 19d agoRegulatoryNegative↗ source
  • Alnylam to launch pivotal Huntington’s trial after early study shows strong huntingtin knockdown
    Alnylam Pharmaceuticals announced plans to move its Huntington’s disease RNAi therapy brezosiran into a pivotal, placebo‑controlled trial slated for 2027, pending regulatory alignment. The decisio…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • Tango Therapeutics reports 82% response rate for vopimetostat plus Rasonque in pancreatic cancer, down from 92% earlier
    Tango Therapeutics announced updated data from its ongoing Phase 1/2 trial combining its PRMT5 inhibitor vopimetostat with Revolution Medicines' newly approved drug Rasonque (daraxonrasib) in secon…
    BioSpace · 19d agoNegative readoutNegative↗ source
  • Lycia Therapeutics raises $317.5 million in IPO as Merck halts sac-TMT trial
    Lycia Therapeutics, founded by Nobel laureate Carolyn Bertozzi, priced its initial public offering at about $317.5 million, bringing total proceeds to roughly $318 million. The offering marks the…
    Endpoints · 19d agoDealNeutral↗ source
  • Pathos AI secures $237M Series E funding at $3B valuation, partners with Bristol Myers on neuroscience
    Pathos AI, an AI-focused biotech based in New York, announced it has closed a Series E financing round raising $237 million. The round values the company at $3 billion, reflecting investor confide…
    Endpoints · 19d agoDealPositive↗ source
  • Warp Sciences raises $215 million Series A to apply AI in drug building-block design
    Former OpenAI head of science Kevin Weil announced the launch of Warp Sciences, a new startup aimed at accelerating the creation of molecular building blocks for drug discovery. The company secure…
    Endpoints · 19d agoDealPositive↗ source
  • Gilead agrees to pay $1.28 billion upfront to China's PepStar for oral IL-23 inflammation drug candidate
    Gilead Sciences announced a deal with Chinese biotech PepStar Therapeutics to acquire an early-stage oral IL-23 inhibitor. The agreement includes an upfront payment of roughly $1.28 billion for Pe…
    Endpoints · 20d agoDealNeutral↗ source
  • BMS reports fatal septic pneumonia in MS patient during CAR T trial of zolacabtagene autoleucel
    BMS disclosed that a participant in its Phase 1 Breakfree-2 study of the CAR T cell therapy zolacabtagene autoleucel died from septic pneumonia. The patient, who had highly active relapsing multip…
    BioSpace · 19d agoNegative readoutNegative↗ source
  • Roche signs up to $813M deal with Zymeworks for preclinical trispecific T cell engager
    Roche announced a partnership with Zymeworks that includes an upfront payment of $55 million for worldwide rights to a trispecific T cell engager currently in preclinical development. The agreemen…
    Endpoints · 19d agoDealPositive↗ source
  • Bristol Myers reports patient death in autoimmune CAR-T trial and explains summer pause
    Bristol Myers Squibb disclosed that a participant in its autoimmune CAR-T cell therapy study has died. The company said the death occurred during the trial and is under investigation, with details…
    Endpoints · 19d agoNegative↗ source
  • US proposes new biotech investment limits on China, but licensing deals remain allowed
    The U.S. Treasury announced a proposal to curb outbound investments in Chinese biotechnology, citing national‑security concerns. The plan would limit U.S. persons from funding certain bio‑derived c…
    BioSpace · 19d agoRegulatoryNeutral↗ source
  • FDA lifts hold on Aardvark Therapeutics' ARD-101 after safety study shows no cardiac events
    FDA has lifted the clinical hold on Aardvark Therapeutics' ARD-101 after the company completed an additional safety study. The new data showed no cardiac events, addressing the concerns that prompt…
    BioSpace · 19d agoCRLPositive↗ source