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  • 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
  • Iran war disruptions ripple through pharma supply chain, raising raw material and shipping costs
    The ongoing conflict between Iran and its adversaries has entered its third month, and analysts are now seeing early signs that the fighting is affecting the pharmaceutical supply chain. Disruptio…
    Endpoints · 3mo agoNegative↗ source
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  • 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
  • Pfizer, Arvinas sell recently approved breast cancer drug to Rigel for $35 million
    Pfizer and its partner Arvinas have agreed to transfer the commercial rights of a breast cancer therapy to Rigel Pharmaceuticals. The drug had just received regulatory approval, marking a mileston…
    Endpoints · 3mo agoDealNegative↗ 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
  • Bayer signals cautious yet aggressive push into pharma acquisitions after five-year pause
    Bayer's CEO Bill Anderson told investors on the first-quarter earnings call that the company is ready to re-enter the pharmaceutical merger-and-acquisition market after a five-year hiatus. He emph…
    Endpoints · 3mo agoDealPositive↗ source
  • Knit Health secures $11.6M seed round to develop doctor-like AI for healthcare operations
    Knit Health, a startup spun out of UC Berkeley, announced it has closed a seed financing round of $11.6 million. The round was co‑led by Uncork Capital, providing the capital the company plans to…
    Endpoints · 3mo agoDealPositive↗ 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 · 4mo 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
  • FDA Commissioner Marty Makary steps down after weeks of uncertainty
    Marty Makary, the commissioner of the U.S. Food and Drug Administration, announced his resignation on Tuesday. The decision came after his employment status was uncertain for several days, accordi…
    Endpoints · 3mo agoRegulatoryNeutral↗ 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 · 4mo agoRegulatoryNeutral↗ source