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  • 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
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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 · 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
  • 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
  • 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
  • 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 · 4mo 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
  • Men less likely to seek suicide help despite higher discussion rates, Crisis Text Line report shows
    The nonprofit Crisis Text Line reviewed 1.5 million text messages it received in 2025 and discovered that fewer than one‑fifth of the users identified as male only. Even though men made up a small…
    STAT · 4mo agoNegative↗ source
  • Alcohol screening often skipped in primary care, raising health costs
    Doctors are expected to ask patients about their alcohol consumption during routine checkups, but many primary care visits omit or rush this conversation. Evidence-based screening tools can be app…
    STAT · 4mo agoNegative↗ source
  • STAT investigates why alcohol remains America’s leading cause of death and calls for Medicaid work requirement exemptions
    STAT’s D.C. Diagnosis newsletter examines why alcohol continues to be the United States' deadliest drug, highlighting its persistent impact on public health. The piece references cultural commenta…
    STAT · 4mo agoNegative↗ source
  • PCOS renamed PMOS after decade-long scientific effort
    A new name for the condition formerly known as polycystic ovary syndrome (PCOS) has been introduced. The term polyendocrine metabolic ovarian syndrome (PMOS) was presented in a paper published in…
    STAT · 4mo agoPositive↗ source
  • Inhibrx reports 44% response rate when paired with Keytruda in head-and-neck cancer Phase 2 trial
    Inhibrx Biosciences said its experimental agent INBRX-106 boosted the activity of Merck's Keytruda in a Phase 2 study of a head-and-neck cancer. The combination achieved a 44% overall response rate…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Astellas revisits gene therapy for XLMTM, offering new hope after earlier setbacks
    A gene therapy for the rare muscle disorder X‑linked myotubular myopathy (XLMTM) showed mixed results in early trials, with some boys experiencing dramatic recoveries while others died. Astellas P…
    STAT · 4mo agoPositive↗ source
  • Supreme Court pauses restrictions, keeps abortion pill mifepristone available through pharmacies and mail
    The Supreme Court issued an order that maintains current access to the abortion medication mifepristone while it reviews a case challenging FDA prescribing rules. The order, signed by Justice Samu…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Colombian court upholds compulsory license for HIV drug, affirming legal framework
    The Court of Justice of the Andean Community ruled that Colombia's issuance of a compulsory license for an HIV medicine two years ago was lawful. The tribunal said the government had a valid publi…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Medicare falls short on projected Alzheimer’s drug costs as fewer seniors use Leqembi
    Bob Herman reports that Medicare's earlier estimate that the new Alzheimer's therapy Leqembi would cost the program $3.5 billion in 2025 has proved far too high. The agency's actuaries based the fo…
    STAT · 4mo agoRegulatoryNegative↗ source
  • FDA policy lets some flavored vapes stay on shelves without full approval, raising expert concerns
    The Food and Drug Administration announced a new guidance that allows certain flavored e-cigarettes and nicotine pouches to remain on the market even though they have not received full authorizatio…
    STAT · 4mo agoRegulatoryNegative↗ source
  • GSK partners with Sino Biopharma to expand access to hepatitis B drug bepirovirsen in China
    GSK announced a marketing agreement with Sino Biopharmaceutical to distribute its experimental hepatitis B therapy bepirovirsen in China. Sino's subsidiary will purchase a supply of the drug and u…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Astellas therapy brings new hope to rare disease patients amid broader biotech challenges
    A new Astellas treatment is being highlighted as a source of optimism for a community affected by a rare disease, after a period of setbacks in the program. The article also notes a revived gene t…
    STAT · 4mo agoPositive↗ source
  • Biotech layoffs slow as companies like BioNTech cut nearly 1,900 jobs amid market pressures
    The biotech sector has seen more than 40 layoff announcements through the end of April 2026, a decline from the over 50 rounds reported in the final months of 2025. Analysts had expected the pace t…
    BioPharma Dive · 4mo agoLayoffsNegative↗ source
  • Medicare uptake of newly approved Alzheimer’s drugs Leqembi and Kisunla falls short of expectations
    Medicare is seeing much lower use of the two Alzheimer’s treatments that received FDA approval earlier this year. The drugs, Leqembi and Kisunla, were expected to generate notable spending for Med…
    STAT · 4mo agoRegulatoryNegative↗ source