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  • FDA approves vepdegestrant for ESR1-mutated ER-positive advanced breast cancer
    On May 1, 2026 the FDA gave its first approval to vepdegestrant, an oral selective estrogen receptor degrader, for adult patients with estrogen receptor-positive, HER2-negative breast cancer that c…
    onclive · 4mo agoApprovalPositive↗ source
  • Bristol Myers Squibb signs up to $15.2 billion partnership with China's Hengrui Pharma
    Bristol Myers Squibb announced a licensing partnership with China's Hengrui Pharma covering more than a dozen early-stage drug programs. The agreement includes a $600 million upfront payment to He…
    STAT · 4mo agoDealPositive↗ source
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  • FDA chief Marty Makary resigns, ending turbulent tenure
    FDA chief Marty Makary has resigned, ending a tenure described as turbulent with leadership upheaval, mass layoffs, political pressure and public disputes with drugmakers. President Trump announce…
    BioPharma Dive · 4mo agoRegulatoryNegative↗ source
  • Bristol Myers Squibb and China's Hengrui Pharma launch $15.2 billion alliance covering up to 13 early-stage drugs
    Bristol Myers Squibb announced a new partnership with Chinese drugmaker Hengrui Pharma that could be worth more than $15.2 billion and includes up to 13 early-stage drug candidates. The deal refle…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Alcohol epidemic claims nearly 500 U.S. lives daily, exposing systemic public-health failures
    The investigative series "The Deadliest Drug" surveyed more than 100 health researchers, clinicians, patients, industry insiders and lawmakers, and examined scientific literature, treatment protoco…
    STAT · 4mo agoNegative↗ source
  • Supreme Court grants three-day extension on ruling over abortion drug mifepristone
    The U.S. Supreme Court announced it will take an additional three days before issuing a decision in the case concerning the abortion medication mifepristone. The case, Louisiana v. FDA, reached th…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Pain drug research gains momentum a year after Vertex launch as new startups revive sodium channel targets
    A year after Vertex introduced its breakthrough pain medication, the field of pain drug development is at a pivotal crossroads. Analysts note that renewed scientific focus and investor interest are…
    BioPharma Dive · 4mo agoPositive↗ source
  • 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 · 4mo 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 · 4mo agoRegulatoryNegative↗ source
  • 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo agoNeutral↗ source