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  • Pharma leaders risk industry collapse by over-relying on Chinese drug sourcing, says analyst
    Olivia Kosloff, a senior fellow at the American Economic Liberties Project and co-chair of a Council on Foreign Relations working group, argues that U.S. pharma and biotech executives are jeopardiz…
    STAT · 3mo agoNegative↗ source
  • Former FDA Commissioner Marty Makary resigns under pressure, critics call his tenure the weakest in 25 years
    Marty Makary stepped down as FDA commissioner on Tuesday after mounting pressure, ending a tenure that many observers described as the weakest in the agency’s recent history. Critics said he lacke…
    STAT · 3mo agoRegulatoryNegative↗ source
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  • EU drafts Critical Medicines Act to increase local production and curb drug shortages
    The European Union has reached a provisional agreement known as the Critical Medicines Act, aimed at strengthening the supply of essential medicines across member states. The plan focuses on incre…
    STAT · 3mo agoRegulatoryPositive↗ source
  • FDA Commissioner Marty Makary resigns amid internal turmoil, top food regulator Kyle Diamantas to serve as acting chief
    Food and Drug Administration Commissioner Marty Makary is leaving his post after serving a little over a year, according to an administration source. His tenure was marked by staff departures and i…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Hims sales dip as telehealth rivals intensify; Bristol partners with Chinese firm, other biotech updates
    Hims reported lower sales this quarter, attributing the shortfall to growing competition from other telehealth providers. Bristol announced a new partnership with Chinese drugmaker Hengrui Pharma…
    STAT · 3mo agoNeutral↗ source
  • Arvinas and Pfizer license newly approved PROTAC breast cancer drug Veppanu to Rigel Pharmaceuticals
    Arvinas and Pfizer have signed a licensing agreement that transfers ownership of their newly approved breast cancer drug, Veppanu, to San Francisco‑based Rigel Pharmaceuticals. The deal gives Arvi…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • FDA grants breakthrough therapy designation to Emi-Le for advanced adenoid cystic carcinoma
    The U.S. Food and Drug Administration has granted breakthrough therapy designation to Emi-Le for patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma (ACC). Phase 1 tri…
    onclive · 3mo agoCRLPositive↗ source
  • Phase 1 trial shows safety and early PSA responses for novel PSMA radioligand in mCRPC
    A Phase 1 study evaluated the long‑circulating PSMA therapeutic radioligand [177Lu]Lu‑D‑Dan‑Phe‑PSMA in patients with metastatic castration‑resistant prostate cancer. The trial enrolled several dos…
    onclive · 3mo agoPositive readoutPositive↗ source
  • FDA warns of secondary cancers linked to tazemetostat in follicular lymphoma and epithelioid sarcoma
    The FDA issued an alert after the voluntary withdrawal of tazemetostat indications for follicular lymphoma and epithelioid sarcoma, emphasizing the drug's association with secondary primary maligna…
    onclive · 3mo agoRegulatoryNegative↗ source
  • Immunotherapy trials like PODIUM-303 are reshaping treatment for squamous cell anal cancer, says Dr Parikh
    Dr Aparna R. Parikh, an oncologist at Massachusetts General Hospital and Harvard professor, highlighted the growing feasibility of immunotherapy studies in squamous cell anal carcinoma (SCAC). She…
    onclive · 3mo agoPositive↗ source
  • Capsida Biotherapeutics still unable to determine cause of child death in brain-targeted gene therapy trial
    Capsida Biotherapeutics reported that it still has no explanation for the death of a child who participated in its CAP-002 gene therapy trial last September. The trial was intended to test a new c…
    STAT · 3mo agoNegative readoutNegative↗ source
  • Alcohol Remains U.S. Deadliest Drug, Killing 178,000 Annually, Study Finds
    STAT’s investigative series "The Deadliest Drug" catalogues the United States' failure to address excessive alcohol use as a leading cause of disease, injury and death. Even as overall drinking ra…
    STAT · 3mo agoNegative↗ source
  • Pharma firms spend $130M lobbying on TrumpRx plan, while Novo Nordisk reports 27.7% weight loss in high‑dose Wegovy trial
    Seventeen pharmaceutical companies that back the White House’s TrumpRx prescription‑drug pricing program collectively spent more than $130 million on federal lobbying in 2025. That represents a ro…
    STAT · 3mo agoNeutral↗ source
  • Honesty and Humor Offer Hope in Breast Cancer Survivorship, Says Dr Nunnery and Survivor Annie Bond
    The Breast Cancer Briefing podcast, hosted by Dr Sara Nunnery of Tennessee Oncology, featured a conversation with Annie Bond, a breast cancer survivor and patient advocate. Bond, who was first dia…
    onclive · 3mo agoPositive↗ source
  • Hims reports $33 million loss after shifting focus to GLP-1 market
    Hims said its latest earnings were hit by a $33 million charge tied to a strategic shift toward GLP-1 treatments. The charge stems from costs of redirecting product development and marketing resou…
    STAT · 3mo agoEarningsNegative↗ source
  • Fox Chase Cancer Center and Labcorp launch study of ultra-sensitive blood test for early-stage lung cancer recurrence
    Fox Chase Cancer Center and Labcorp announced a new clinical trial to evaluate a tumor-informed, whole-genome sequencing ctDNA minimal residual disease (MRD) assay for early-stage non-small cell lu…
    onclive · 3mo agoPositive↗ source
  • Experts highlight unmet needs and emerging role of antibody drug conjugates in endometrial cancer
    Experts note that significant unmet needs persist in endometrial cancer even as antibody drug conjugates (ADCs) begin to expand treatment options. They suggest ADCs could address gaps in recurrent…
    onclive · 3mo agoNeutral↗ source
  • Experts discuss emerging therapies shaping the future of relapsed and refractory multiple myeloma
    In a recent opinion segment, Dr. Ajay Nooka and Dr. Noopur Raje explore how new treatments and ongoing trials are influencing the landscape for patients with relapsed and refractory multiple myelom…
    onclive · 3mo agoNeutral↗ source
  • Experts discuss emerging MET-driven resistance data shaping second-line therapy for EGFR-mutated lung cancer
    In a recent video segment, Dr. Jacob Sands sits down with Dr. Heather Wakelee to talk about the impact of new findings on MET-driven resistance in EGFR‑mutated non‑small cell lung cancer. The conv…
    onclive · 3mo agoNeutral↗ source
  • Sequencing antibody-drug conjugates adds complexity to recurrent endometrial cancer treatment
    Therapy sequencing for recurrent endometrial cancer is becoming increasingly complex as immunotherapy moves earlier in the treatment pathway and antibody-drug conjugates (ADCs) gain traction. Expe…
    onclive · 3mo agoNeutral↗ source
  • Experts highlight need for broader monitoring in polycythemia vera as patient shows disease progression despite controlled hematocrit
    A 68-year‑old woman with a six‑year history of polycythemia vera (PV) and prior deep‑vein thrombosis has kept her hematocrit below 45% on hydroxyurea, indicating good control of that metric. Desp…
    onclive · 3mo agoNeutral↗ source
  • New sepsis AI models face adoption hurdles despite improved performance
    Hospitals once embraced an Epic sepsis‑prediction algorithm that promised early alerts for a condition that kills over 350,000 Americans each year. In practice the tool generated far more alerts th…
    STAT · 3mo agoNeutral↗ source
  • Patient groups seek Medicaid work requirement exemptions for HIV and sickle cell patients
    Patient groups are urging the federal government to exempt certain disease populations from a new Medicaid work requirement rule. The rule, added by a 2017 tax bill, would require beneficiaries to…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • AUA and SUO Issue 2026 Update to Advanced Prostate Cancer Guideline
    The American Urological Association (AUA) and the Society of Urologic Oncology (SUO) have released an amendment to their Advanced Prostate Cancer Guideline for 2026. The update revises recommendat…
    onclive · 3mo agoNeutral↗ source
  • Delayed and re-emergent immune-related adverse events can persist years after melanoma checkpoint therapy, says expert
    Dr. Michael A. Postow, chief of the Melanoma Service at Memorial Sloan Kettering Cancer Center, explained that immune checkpoint inhibitors (ICIs) for melanoma have a distinct toxicity profile comp…
    onclive · 3mo agoNeutral↗ source