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  • FDA commissioner Marty Makary faces possible dismissal amid political pressure, while new insights link menstrual cycles to mental health
    Theresa Gaffney’s Morning Rounds newsletter highlighted a growing body of research that connects menstrual cycle patterns with fluctuations in mental health, underscoring the importance of gender‑s…
    STAT · 5mo agoNeutral↗ source
  • AI dependence mirrors addiction, warns psychiatrist, sparking debate on hidden costs
    Jonathan Avery, vice chair for addiction psychiatry at Weill Cornell Medicine, reflects on his podcast about addiction and the mixed feedback he receives. In a recent episode he interviewed NYU ne…
    STAT · 5mo agoNeutral↗ source
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Dermatophilosis identified in clusters of European gay men, a mild livestock skin disease
Researchers in France and Spain have diagnosed several men who have sex with men with dermatophilosis, a bacterial skin infection normally seen in livestock. The cases occurred without any known c…
STAT · 5mo agoNeutral↗ source
  • Nivolumab added to standard radiation and hormone therapy yields 90% two-year disease control in high-risk prostate cancer
    A Phase 2 trial evaluated the combination of nivolumab with standard radiation and hormone therapy in patients with high‑volume grade group 5 prostate cancer. The study reported a 2‑year freedom f…
    onclive · 5mo agoPositive readoutPositive↗ source
  • OncLive highlights key advances in ovarian, Hodgkin lymphoma, pancreatic, melanoma and myelofibrosis therapies
    The weekly "Five Under 5" roundup from OncLive curates the most notable oncology video content released during the first week of May. It spotlights recent data across a range of cancer types, offer…
    onclive · 5mo agoNeutral↗ source
  • FDA approves zenocutuzumab for previously treated NRG1-fusion cholangiocarcinoma
    The FDA has granted approval for zenocutuzumab to treat patients with previously treated, advanced cholangiocarcinoma that carries an NRG1 fusion. The decision was based on data from the eNRGy stud…
    onclive · 5mo agoApprovalPositive↗ source
  • Antibody-drug conjugates poised to move lung cancer treatment earlier, boosting response rates and targeting brain metastases
    Experts highlight that antibody‑drug conjugates are reshaping non‑small cell lung cancer therapy, moving beyond their traditional role in later‑line settings. The new agents have demonstrated high…
    onclive · 5mo agoPositive↗ source
  • Experts criticize CDC's limited role as hantavirus outbreak spreads on cruise ship
    Health officials are dealing with a hantavirus outbreak affecting passengers on a cruise ship, and the World Health Organization has taken the lead in coordinating the response. The U.S. Centers fo…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Endpoints Weekly highlights biotech company models, a quirky startup story, and earnings season updates
    The latest edition of Endpoints Weekly introduces a look at emerging biotech company structures, noting how new models are reshaping the industry. It also features a light‑hearted piece about a st…
    Endpoints · 5mo agoNeutral↗ source
  • Dr. Glaucomflecken urges national focus on medicine’s corporatization in First Opinion podcast
    The First Opinion podcast featured an interview with ophthalmologist and comedian Will Flanary, better known as Dr. Glaucomflecken. He discussed his views on the growing corporatization of medicine…
    STAT · 5mo agoNeutral↗ source
  • Opinion piece questions bioethical basis of RFK Jr’s alleged raccoon penis collection
    An opinion article highlights a claim that Robert F. Kennedy Jr. once removed the penis of a dead raccoon in 2001. The allegation was first reported in a recent biography and cited during a congres…
    STAT · 5mo agoNegative↗ source
  • Zongertinib Shows 76% Response Rate in HER2-Mutant NSCLC, Paving Way for Accelerated FDA Approval
    Zongertinib achieved a 76% overall response rate and a median response duration of 15.2 months in treatment‑naïve patients with HER2‑mutant advanced or metastatic non‑small cell lung cancer. The da…
    onclive · 5mo agoApprovalPositive↗ source
  • Roche to acquire PathAI for $750 million to boost AI pathology
    Roche announced it will acquire Boston based PathAI for an upfront payment of $750 million. The acquisition follows a partnership that began in 2021 and is intended to speed the use of artificial i…
    STAT · 5mo agoDealPositive↗ source
  • Lilly adds $4.5 billion to Indiana manufacturing to boost weight-loss drug supply
    Eli Lilly & Co. announced an additional $4.5 billion investment in two of its three manufacturing sites in Lebanon, Indiana. The funding is aimed at expanding capacity for both its genetic therapie…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • Capivasertib plus fulvestrant shows numerical overall-survival gain in PIK3CA/AKT1/PTEN-altered advanced breast cancer
    The CAPItello-291 phase III trial enrolled 708 patients with advanced breast cancer and randomized them 1:1 to receive capivasertib (400 mg twice daily on a 4‑on/3‑off schedule) plus fulvestrant, o…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Former FDA officials and pharma groups weigh in as Supreme Court considers mifepristone regulation
    The Supreme Court is expected to act on a case involving the abortion pill mifepristone after a pause on a federal appeals court order that halted mail‑order distribution. The decision could resha…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • Medicare’s new RAPID coverage pathway speeds adult device access, but pediatric devices still lag
    The Centers for Medicare and Medicaid Services and the FDA introduced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. The new process promises Medicare natio…
    STAT · 5mo agoRegulatoryPositive↗ source
  • Odyssey Therapeutics raises $279 million in IPO, adds $25 million private sale
    Odyssey Therapeutics, a biotech focused on autoimmune diseases, completed an initial public offering that generated $279 million by selling 15.5 million shares at $18 each. The company also secured…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • Pimicotinib shows 76% response rate and functional benefits in TGCT phase 3 trial
    Dr. Randall discussed results from the phase 3 MANEUVER trial of the CSF-1 receptor inhibitor pimicotinib in patients with tenosynovial giant cell tumor (TGCT). The data were presented at the 2025…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Biomarker-directed therapies reshape GI cancer treatment, says expert
    In a recent OncLive On Air podcast, host Courtney Flaherty spoke with Dr. Michael J. Pishvaian about the growing role of biomarker-directed strategies in gastrointestinal oncology. Dr. Pishvaian n…
    onclive · 5mo agoNeutral↗ source
  • FDA approves Zenocutuzumab for NRG1 fusion-positive advanced cholangiocarcinoma
    The U.S. Food and Drug Administration has granted approval for zenocutuzumab-zbco, marketed as Bizengri, to treat adult patients with NRG1 fusion‑positive advanced, unresectable or metastatic chola…
    onclive · 5mo agoApprovalPositive↗ source
  • Trump reportedly plans to dismiss FDA Commissioner Marty Makary
    Multiple media outlets report that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The reports say the decision has not been finalized and could still be…
    Endpoints · 5mo agoRegulatoryNegative↗ source
  • WSJ reports Trump plans to fire FDA Commissioner Marty Makary, decision not yet final
    The Wall Street Journal reported that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The report said the administration has not yet made a final decisi…
    Endpoints · 5mo agoRegulatoryNegative↗ source
  • Daiichi Sankyo writes off $950 million after abandoning ADC manufacturing plan
    Daiichi Sankyo announced it will abandon its planned antibody-drug conjugate (ADC) manufacturing facility. The company said the decision follows a serious over-estimate of third-party demand for AD…
    Endpoints · 5mo agoEarningsNegative↗ source
  • Giants of Cancer Care Unveils 14th Annual Class of Oncology Innovators
    OncLive announced the 14th Annual Giants of Cancer Care inductees, a program that honors oncology leaders whose research, education, mentorship and patient‑focused work have reshaped cancer treatme…
    onclive · 5mo agoPositive↗ source