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  • Sanofi requests removal of teplizumab from FDA fast-track voucher program after director dispute
    Sanofi has formally asked the Food and Drug Administration to withdraw its type 1 diabetes therapy, teplizumab, from the new speedy review voucher program overseen by Commissioner Marty Makary. Th…
    STAT · 6mo agoRegulatoryNegative↗ source
  • Bayer to buy Perfuse for up to $2.45B, bolstering eye drug pipeline
    Centered around a glaucoma therapy in mid-stage testing, the deal is Bayer’s first drug company acquisition in several years and potentially its largest since it purchased AskBio in 2020.
    BioPharma Dive · 6mo agoDealNeutral↗ source
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  • Color Health expands into cancer treatment coordination with virtual tumor boards
    Color Health, a telehealth firm that currently coordinates cancer screening, is moving into providing and coordinating actual cancer care services. CEO Othman Laraki says the growing complexity of…
    STAT · 6mo agoPositive↗ source
  • FDA authorizes fruit-flavored vapes amid political pressure, sparking debate over youth risk and quitting aid
    The U.S. Food and Drug Administration granted its first authorization for fruit-flavored e-cigarettes on Tuesday, adding mango- and blueberry-tasting products from Los Angeles-based Glas to its app…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Experts preview top HR+ and HER2+ breast cancer abstracts ahead of ASCO 2026
    Preparations are under way for the 2026 ASCO Annual Meeting, and breast cancer updates are generating strong interest among clinicians. Leading oncologists including Dr. Yara Abdou of UNC, Dr. VK…
    onclive · 6mo agoNeutral↗ source
  • PhRMA launches seven-figure ad campaign against 340B drug discount program
    PhRMA, the leading pharmaceutical lobbying group, announced a new advertising push aimed at the federal 340B drug discount program. The campaign, described as a seven-figure effort, is set to begi…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Phase 3 MANEUVER trial shows pimicotinib improves response and pain in advanced TGCT, supporting FDA NDA acceptance
    The phase 3 MANEUVER study evaluated pimicotinib in patients with advanced diffuse tenosynovial giant cell tumor. The trial compared the oral agent to placebo and collected both clinical and patien…
    onclive · 6mo agoPositive readoutPositive↗ source
  • STAT+: How a global effort to explore the ‘dark proteome’ is upending our understanding of human disease
    An international team has found thousands of mini-proteins, including some involved in cell division and DNA repair, as well as several unique to cancer cells.
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Health AI progress limited by bad data, newsletter notes
    The latest AI Prognosis newsletter highlights that the quality of health data is a major obstacle for building useful AI tools in medicine. The author explains that many existing datasets contain…
    STAT · 6mo agoNeutral↗ source
  • Higher PD-L1 levels linked to poorer outcomes in EGFR-mutated NSCLC treated with first-line osimertinib
    Dr. Jonathan Wennan Lee, a chief hematology/oncology fellow at Weill Cornell Medicine, discussed the emerging role of PD-L1 as a predictive biomarker for first-line osimertinib resistance in EGFR-m…
    onclive · 6mo agoNegative readoutNeutral↗ source
  • Experts discuss next-generation pathology and precision care for non-small cell lung cancer in new CME podcast
    The CME podcast released on May 6, 2026 brings together Sanja Dacic, Isabel Preeshagul, and Soo-Ryum (Stewart) Yang to review recent advances in pathology for non-small cell lung cancer. The exper…
    onclive · 6mo agoNeutral↗ source
  • HHS focuses on overmedication as cruise ship hantavirus outbreak prompts port change
    The Health and Human Services department announced new efforts to curb excessive prescribing, highlighting concerns about overmedication in the United States. At the same time, a cruise ship ancho…
    STAT · 6mo agoNeutral↗ source
  • OpenAI’s health AI policy blueprint seen as reasonable yet self‑serving, experts say
    OpenAI has expanded its health‑focused AI tools, rolling out ChatGPT Health for consumers, a hospital‑oriented ChatGPT for Healthcare, and a version for clinicians. Alongside the clinician chatbot,…
    STAT · 6mo agoRegulatoryNegative↗ source
  • PeaceHealth abandons plan to outsource Oregon emergency doctors to ApolloMD after lawsuit and local opposition
    PeaceHealth, a nonprofit health system in Oregon, announced Wednesday that it will not move its emergency department staffing to the national physician staffing firm ApolloMD. The decision reverse…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Dr McGregor on the DAD-IO Trial of Sacituzumab Govitecan and EV in Metastatic Urothelial Carcinoma
    Bradley McGregor, MD, discusses the background and design of the phase 1/2 DAD-IO trial in metastatic urothelial carcinoma.
    onclive · 6mo agoNeutral↗ source
  • Dementia care faces ambiguous loss, a unique grief that strains relationships
    Jason Karlawish, a professor of medicine and neurology at the University of Pennsylvania, wrote an opinion piece on the concept of ambiguous loss in dementia care. He reflects on a recent interview…
    STAT · 6mo agoNeutral↗ source
  • Dr. Glaucomflecken protests corporate staffing of PeaceHealth emergency department in Oregon
    Dr. Glaucomflecken, the online persona of physician Will Flanary, hosts the First Opinion Podcast where he blends humor with health‑care commentary. He has become a vocal critic of PeaceHealth’s p…
    STAT · 6mo agoNegative↗ source
  • Iopofosine I-131 shows high response rates and durable disease control in Waldenstrom macroglobulinemia trial
    The 12‑month follow‑up from the CLOVER‑WaM study reports that patients receiving Iopofosine I‑131 achieved strong clinical activity in Waldenstrom macroglobulinemia. In the per‑protocol group, the…
    onclive · 6mo agoPositive readoutPositive↗ source
  • Cytokinetics' Myqorzo meets primary goals in Phase 3 trial for non-obstructive hypertrophic cardiomyopathy
    Cytokinetics announced that its experimental therapy Myqorzo achieved its primary endpoints in a Phase 3 study of patients with non-obstructive hypertrophic cardiomyopathy (HCM). The trial showed…
    BioPharma Dive · 6mo agoPositive readoutPositive↗ source
  • Cytokinetics’ Myqorzo hits twin efficacy targets in genetic heart disease trial, while Viridian reports positive Phase 3 data for elegrobart
    Cytokinetics announced that its experimental heart‑failure drug Myqorzo achieved both primary efficacy endpoints in a study of patients with genetic cardiomyopathy, showing significant symptom impr…
    STAT · 6mo agoPositive readoutPositive↗ source
  • Vertex Q1 revenue slightly below forecasts as key drug sales miss estimates, but Alyftrek revenue surges
    Vertex Pharmaceuticals reported first‑quarter revenue of about $3 billion, falling just short of Wall Street expectations. The modest miss left the stock largely unchanged on the day of the release…
    BioPharma Dive · 6mo agoEarningsNeutral↗ source
  • Cytokinetics' Myqorzo hits both primary endpoints in Phase 3 trial for non-obstructive hypertrophic cardiomyopathy
    Cytokinetics announced that its drug Myqorzo achieved the dual efficacy targets in the Phase 3 ACACIA trial, which evaluated patients with non-obstructive hypertrophic cardiomyopathy (HCM), an inhe…
    STAT · 6mo agoPositive readoutPositive↗ source
  • Hantavirus outbreak on cruise ship highlights risks of U.S. exclusion from WHO
    Three passengers have died and seven others are ill after a suspected hantavirus infection was identified on a cruise vessel anchored off Cape Verde. The World Health Organization has taken the lea…
    STAT · 6mo agoRegulatoryNegative↗ source
  • J&J's IBD combo therapy misses statistical goal but will be tested in a focused patient subgroup
    Johnson & Johnson reported that its experimental combination of Tremfya and Simponi, called JNJ-4804, did not achieve a statistically significant improvement in a Phase 2b study of inflammatory bow…
    STAT · 6mo agoNegative readoutNegative↗ source
  • Expert outlines how to manage common skin and GI side effects of daraxonrasib in pancreatic cancer
    Dr Pant, MD, a professor at MD Anderson Cancer Center, discussed the safety profile of daraxonrasib, a RAS(ON) multi-selective inhibitor being studied in pancreatic ductal adenocarcinoma. The drug…
    onclive · 6mo agoNeutral↗ source