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  • Yusol International Foods recalls OLA-OLA Pounded Yam over undeclared milk allergen
    Fayus Inc., operating as Yusol International Foods, announced a voluntary recall of its OLA-OLA Pounded Yam product after discovering that some packages contain sodium caseinate, a milk-derived ing…
    fda recalls · 2mo agoCRLNegative↗ source
  • Vidcon highlights mental-health challenges faced by social video creators
    Vidcon this year devoted a significant portion of its programming to the mental health of content creators, reflecting growing concern about the pressures of online fame. In a STATus Report interv…
    STAT · 2mo agoNeutral↗ source
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  • Chile's Frutas y Hortalizas del Sur recalls frozen organic blueberries over possible E. coli O145 contamination
    Frutas y Hortalizas del Sur S.A., based in San Carlos, Chile, announced a recall of its frozen GreenWise Organic IQF Blueberries (10‑oz) because the product may be contaminated with Escherichia col…
    fda recalls · 2mo agoCRLNegative↗ source
  • Mars Petcare voluntarily recalls two lots of Pedigree high-protein wet dog food over possible metal and plastic contamination
    Mars Petcare US announced a voluntary recall of two lots of Pedigree Can High Protein Chopped Chicken & Duck Flavor wet dog food (13.2 oz) after discovering potential foreign material. The recall…
    fda recalls · 2mo agoCRLNegative↗ source
  • Roche’s divarasib shows survival benefit over Amgen and BMS drugs in KRAS G12C lung cancer trial
    Roche reported that its experimental KRAS G12C inhibitor divarasib extended overall survival and progression‑free survival in a Phase 3 head‑to‑head study against Amgen’s Lumakra and Bristol Myers…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • FDA grants first clearance for patient-facing LLM diabetes app, marking historic step for AI in medical software
    UpDoc's diabetes management app received FDA clearance, the first for software that uses patient-facing large language models. The app is designed to help patients follow treatment plans set by th…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Celea Therapeutics raises $180 million to advance next-generation IPF drug deupirfenidone
    Celea Therapeutics, a PureTech Health spinout, announced a $180 million venture round to fund development of its next-generation idiopathic pulmonary fibrosis (IPF) therapy, deupirfenidone. The ro…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Roche announces drug that sets new benchmark for KRAS‑driven lung cancer
    Roche has announced a new therapy that it says establishes a new standard of care for patients with KRAS‑driven lung cancer. The announcement was featured in a STAT+ newsletter, underscoring the p…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Biotech Index Surges 30% Year-to-Date as Market Rally Accelerates
    Mid-year data show the biotech sector continuing a strong rally that began in April 2025. The XBI index, the most-watched biotech gauge, rose 19% in June and is up about 30% for the year, trading…
    STAT · 2mo agoPositive↗ source
  • Abiomed recalls Impella CP Sets with SmartAssist over low purge pressure risk
    Abiomed has issued a recall of specific Impella CP Sets with SmartAssist after discovering that the units do not meet design specifications. The defect can cause low purge pressure events from the…
    fda medwatch · 2mo agoCRLNegative↗ source
  • Medicare proposes 33% cut to 340B drug payments for hospitals
    Medicare has released a proposal to cut payments to hospitals for drugs bought through the 340B discount program by more than a third. Under the plan, Medicare would reimburse hospitals at the aver…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Lawmakers ask HHS to compel Eli Lilly to resume 340B hospital discounts
    A bipartisan group of congressional lawmakers has written to HHS Secretary Robert F. Kennedy Jr., urging the department to require Eli Lilly to restore 340B drug discounts for hospitals. Lilly hal…
    STAT · 2mo agoRegulatoryNegative↗ source
  • U.S. Judge Blocks Colorado Panel’s Attempt to Cap Amgen’s Enbrel Price
    A federal judge in the United States issued an order that prevents a Colorado state panel from imposing a price cap on Amgen’s blockbuster arthritis drug Enbrel. The ruling effectively blocks the s…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Federal judge halts Colorado price cap on Amgen's Enbrel drug
    A U.S. district judge issued an injunction that stops the Colorado Prescription Drug Affordability Board from imposing a payment limit on Enbrel, a high-volume biologic sold by Amgen. The court fou…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Former FDA AI regulator says biopharma is misreading agency's guidance, leading to overly cautious approaches
    Tala Fakhouri, who wrote AI policy at the FDA, left the agency last summer and now serves as chief AI and regulatory strategy officer at contract research organization Parexel. She says biopharma…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Genetix, formerly Bluebird Bio, claims rapid turnaround and aims to treat 1,000 sickle-cell patients annually by 2030
    David Meek completed a distressed buyout of Bluebird Bio last year and has rebranded the company as Genetix. He says the transaction rescued the firm from the brink of bankruptcy and set it on a pa…
    STAT · 2mo agoDealPositive↗ source
  • Elevance Health sues CMS, claiming $115 million loss from disputed Medicare Advantage star rating recalculation
    Elevance Health filed a lawsuit in the U.S. District Court for the Southern District of Georgia, alleging that the Centers for Medicare & Medicaid Services (CMS) recalculated its Medicare Advantage…
    STAT · 2mo agoRegulatoryNegative↗ source
  • CDC leadership accused of stifling vaccine effectiveness studies and reshaping advisory committee role
    Ben Lopman, a professor of epidemiology and global health at Emory University, wrote an opinion piece warning that CDC leadership is trying to manufacture a scientific debate about vaccines where n…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 2mo agoCRLNegative↗ source
  • Protillion Biosciences appoints Robert Hollingsworth as chief scientific officer
    Protillion Biosciences announced the hiring of Robert Hollingsworth as its new chief scientific officer. Hollingsworth joins Protillion after serving as chief scientific officer at Shoreline Therap…
    STAT · 2mo agoNeutral↗ source
  • Loss of Colorado Rep. Diana DeGette removes a knowledgeable voice for biopharma in Congress
    Colorado Democratic Rep. Diana DeGette was defeated in her primary, ending her service in the U.S. House of Representatives. DeGette was widely recognized for her deep understanding of biopharma p…
    STAT · 2mo agoNegative↗ source
  • Teen use of AI mental-health chatbots jumps 40% in a year, experts call for safety rules
    A recent study published in JAMA Pediatrics found that the proportion of adolescents turning to AI chatbots for mental-health advice rose from roughly one in eight to one in five within a single ye…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Heat waves become more frequent and intense, raising health risks for Americans as presidential fitness test returns
    Recent data show that heat waves across the United States are occurring more often, lasting longer, and reaching higher temperatures, which experts say could increase health problems such as heat e…
    STAT · 2mo agoNeutral↗ source
  • Gellert Global Group recalls ALDI Fusia Kimchi & Tofu Kimbap over undeclared tuna
    Gellert Global Group of Elizabeth, NJ announced a recall of 8.1-oz packages of ALDI's Fusia Asian Inspirations Kimchi & Tofu Kimbap because they may contain undeclared tuna. The undeclared fish po…
    fda recalls · 2mo agoCRLNegative↗ source
  • Presidential fitness test returns as a modest push for youth activity, experts caution limits
    The health secretary reintroduced a presidential fitness test as part of a campaign to boost youth health and address rising sedentary habits. Experts say the test is a positive step but not a com…
    STAT · 2mo agoNeutral↗ source