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1,045 stories matching this filter · ← front page

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  • Novartis and Novo Nordisk see back-to-back cardiovascular trial failures, raising doubts for the field
    Novartis announced that its experimental heart‑protective therapy, pelacarsen, did not meet its primary endpoints in a seven‑year study designed to cut heart attacks and strokes by lowering lipopro…
    STAT · 13h agoNegative readoutNegative↗ source
  • Revolution Medicines secures FDA approval for Rasonque, a RAS inhibitor targeting advanced pancreatic cancer
    Revolution Medicines announced FDA approval of its RAS inhibitor Rasonque for patients with advanced pancreatic cancer, marking a milestone for the company. The approval is seen as a breakthrough…
    Fierce Biotech · 11h agoApprovalPositive↗ source
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  • Cancer drug shortages persist, hampering patient care and highlighting lasting impacts of platinum chemotherapy
    The STAT+ newsletter reports that cancer treatment centers continue to struggle with ongoing shortages of key oncology drugs, forcing clinicians to alter or delay therapy for patients. These short…
    STAT · 7h agoNegative↗ source
  • RA Capital backs four biotech rounds in September as Novartis shares tumble after trial setbacks
    RA Capital Management participated in four biotech financings in September, including Series A rounds for Solstice Oncology and Tectora Therapeutics, as well as co-leading a $56 million round for T…
    BioPharma Dive · 6h agoDealNeutral↗ source
  • Novartis investors grow wary as drug setbacks spark scrutiny of M&A strategy
    Investors in Novartis are intensifying their examination of the company’s recent dealmaking after a series of setbacks involving drugs that were brought in through mergers and acquisitions. The hei…
    STAT · 7h agoNegative↗ source
  • Karyopharm Secures One-Month Debt Extension While Awaiting Xpovio Decision
    Karyopharm Therapeutics, facing cash constraints, has negotiated a temporary reprieve on a $15.8 million debt that was due. Under the agreement, lenders and noteholders will refrain from enforceme…
    BioPharma Dive · 7h agoDealNeutral↗ source
  • FDA pushes back decision on Exelixis' zanzalintinib and Roche's Tecentriq combo for metastatic colorectal cancer
    The FDA announced a delay in its decision on the approval of Exelixis' oral kinase inhibitor zanzalintinib when used with Roche's Tecentriq for metastatic colorectal cancer. The agency said it nee…
    Fierce Biotech · 11h agoRegulatoryNegative↗ source
  • U.S. declares end to record cyclospora outbreak linked to iceberg lettuce
    U.S. health officials announced Friday that the nation’s largest cyclospora food‑poisoning outbreak is officially over. The outbreak, which affected 21 states, was tied to contaminated iceberg lett…
    STAT · 4h agoNeutral↗ source
  • CMS guidance lets states use tier system to exempt medically frail Medicaid recipients from work requirements
    The Centers for Medicare and Medicaid Services issued new guidance that permits individual states to apply a tiered approach when deciding which Medicaid enrollees qualify as medically frail and th…
    STAT · 6h agoRegulatoryNeutral↗ source
  • mRNA cancer vaccines’ biggest barriers to market
    Manufacturing hurdles are just one challenge the industry must overcome to commercialize personalized mRNA cancer vaccines.
    BioPharma Dive · 9h agoRegulatoryNeutral↗ source
  • Boycott Targeting American Diabetes Association Expands to Include Medical Journal
    A new boycott has been launched against the American Diabetes Association (ADA). The campaign also calls on a medical journal to join the effort, signaling broader criticism of the organization. T…
    STAT · 9h agoNegative↗ source
  • FDA grants three-month review extension for Exelixis' metastatic colorectal cancer candidate
    Exelixis, a California drug developer, has provided the FDA with additional safety and efficacy data for its experimental therapy aimed at treating metastatic colorectal cancer. The agency respond…
    Endpoints · 5h agoRegulatoryNeutral↗ source
  • Alloy Therapeutics appoints Venkat Krishnamurthy as chief scientific officer of genetic medicines unit
    Alloy Therapeutics announced the hiring of Venkat Krishnamurthy as chief scientific officer for its genetic medicines division. Krishnamurthy previously held the same role at Flashpoint Therapeuti…
    STAT · 6h agoNeutral↗ source
  • Thoracic surgeon warns that 9/11 exposure continues to cause lung cancer and mesothelioma decades later
    Raja Flores, a thoracic surgeon at Mount Sinai, treats patients whose illnesses trace back to the dust and fumes of the World Trade Center collapse. He describes how many former first responders an…
    STAT · 13h agoNeutral↗ source
  • Cancer drug shortages persist at US centers, survey shows many face multiple medication gaps
    An ongoing shortage of cancer medicines is forcing leading US cancer centers to adopt work-around strategies, and a majority say clinical trials have been disrupted, a new survey reports. All cent…
    STAT · 1d agoRegulatoryNegative↗ source
  • Study finds childhood platinum chemotherapy ages liver cells, may increase future cancer risk
    A new study published in Science examined children who received platinum‑based chemotherapy, such as cisplatin or carboplatin, followed by surgery for hepatoblastoma. Researchers collected samples…
    STAT · 1d agoNegative readoutNegative↗ source
  • Novartis shareholder urges board overhaul after share plunge tied to trial setbacks
    A prominent Novartis investor has publicly called for a revamp of the company’s board, arguing that stronger governance is needed after the stock experienced a record decline. The demand was voice…
    STAT · 1d agoNegative↗ source
  • New FDA Oncology Center chief Angelo de Claro pledges AI integration and trial expansion
    Angelo de Claro, M.D., has taken over as the permanent head of the FDA’s Oncology Center of Excellence after serving as acting director since late 2025. In his first interview, he said the agency w…
    Fierce Biotech · 21h agoRegulatoryNeutral↗ source
  • Two promising heart drugs fail, podcast examines why
    The latest episode of The Readout LOUD looked at two experimental therapies that had been billed as the next breakthrough in treating heart disease. The discussion highlighted how billions of dolla…
    STAT · 1d agoNegative readoutNegative↗ source
  • Shionogi's mid-stage stroke drug redasemtide fails, while Bayer's Hyrnuo receives expanded NSCLC label
    Shionogi reported that its experimental stroke therapy redasemtide did not achieve the primary endpoint in a mid-stage clinical trial, marking a setback for the company’s neurology pipeline. The f…
    Endpoints · 1d agoNegative readoutNeutral↗ source
  • FDA expands approval for Bayer's lung cancer therapy
    The U.S. Food and Drug Administration announced an expansion of the approved use of Bayer's lung cancer drug. The decision broadens the patient population eligible for the treatment, reflecting th…
    STAT · 1d agoApprovalPositive↗ source
  • Reverse mergers surge as biotech firms seek public listings via shell companies
    Reverse mergers, once dismissed, are now a common route for biotech startups to gain a public listing by merging with shell companies. Data from JB Strategy Partners shows roughly two dozen such d…
    BioPharma Dive · 1d agoDealNegative↗ source
  • BridgeBio Oncology shares tumble 24% as it narrows KRAS program focus
    BridgeBio Oncology Therapeutics saw its stock drop sharply after announcing a strategic shift. The company said it will scale back its broader pipeline to concentrate resources on its lead KRAS in…
    Endpoints · 1d agoNegative↗ source
  • Roivant's mosliciguat shows strong efficacy in Phase 2 PH-ILD trial
    Roivant's experimental drug mosliciguat achieved strong efficacy signals in a Phase 2 study of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The mid-stage trial met its…
    STAT · 1d agoPositive readoutPositive↗ source
  • Takeda R&D chief Andy Plump to retire after string of recent FDA approvals
    Takeda's long-serving research and development president Andy Plump will step down in June. He joined the Japanese drugmaker in 2015 from Sanofi and has led the R&D organization since then. His ex…
    Fierce Biotech · 1d agoPositive↗ source