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  • Former ARPA-H director launches startup to solve AI's basic challenges in health care
    A former director of the U.S. Advanced Research Projects Agency for Health has founded a new company focused on fixing what he calls the "dumb problems" of artificial intelligence in medicine. The…
    STAT · 6d agoNeutral↗ source
  • Ig Nobel Prizes move to Zurich as organizers cite US immigration concerns
    The Ig Nobel Prizes, a tongue-in-cheek science award, will be held outside the United States for the first time since they began in 1991. Organizers said the move to Zurich, Switzerland, reflects…
    STAT · 6d agoNeutral↗ source
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Frutas y Hortalizas del Sur expands recall to include Great Value organic triple berry blend over possible E. coli O145 contamination
On September 2, 2026, Frutas y Hortalizas del Sur S.A. announced that it is expanding the recall it issued on July 3, 2026 for frozen organic IQF blueberries. The expansion adds one lot of Great V…
fda recalls · 5d agoCRLNegative↗ source
  • Roche signs $1.53 billion licensing deal with Simcere for preclinical B-cell antibody
    Roche announced a licensing agreement with China's Simcere Zaiming, paying $75 million upfront and potentially up to $1.53 billion in total, for worldwide rights to a preclinical trispecific antibo…
    Fierce Biotech · 7d agoDealPositive↗ source
  • GSK's mRNA flu vaccine shows stronger immune response than standard shots in phase 2, prompting phase 3 launch
    GSK reported that its experimental mRNA seasonal influenza vaccine generated higher immune responses than both standard and high-dose flu shots in a phase-2 study involving nearly 1,000 adults. Th…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • Novartis reports positive multiple sclerosis results with its BTK inhibitor
    Novartis announced that its BTK inhibitor has shown a positive outcome in a multiple sclerosis study, marking a notable advance for the company in this therapeutic area. The result highlights the…
    STAT · 7d agoPositive readoutPositive↗ source
  • Medtronic recalls Bravo CF reflux monitoring capsule after 184 serious injuries reported
    Medtronic has issued a recall of its Bravo CF esophageal pH monitoring capsule, a wireless device used to assess acid reflux. The recall follows an FDA early alert after the company identified a pr…
    Fierce Biotech · 7d agoCRLNegative↗ source
  • Boston Scientific stops sales of Imager II catheters after tip defect linked to two injuries
    Boston Scientific issued a letter on August 24 advising customers to remove all Imager II angiographic catheters from use or sale after discovering a manufacturing problem. The problem involves re…
    Fierce Biotech · 7d agoCRLNegative↗ source
  • Trump administration announces new drug pricing pledges, but details remain undisclosed
    On Monday the Trump administration said a second group of pharmaceutical companies had agreed to cut drug prices to levels similar to those in other countries. The companies involved have pledged t…
    STAT · 6d agoDealNegative↗ source
  • Novartis and Bristol Myers Squibb pause cell therapy trials; $480K cancer drug price now routine, new pricing deals announced
    Novartis and Bristol Myers Squibb have announced pauses in several of their cell therapy trials, citing operational considerations. The pauses affect multiple programs but the companies did not det…
    STAT · 7d agoDealNeutral↗ source
  • FDA clears Stryker’s surgical cockpit that integrates Apple Vision Pro VR headset
    FDA has given clearance for Stryker's new surgical cockpit system that incorporates Apple's Vision Pro VR headset, marking a regulatory milestone for the integration of consumer VR technology in th…
    STAT · 7d agoRegulatoryPositive↗ source
  • Study finds Paxlovid ineffective for treating long Covid
    A recent study reported that the antiviral Paxlovid did not provide measurable benefit for patients suffering from long Covid symptoms. Researchers observed no significant improvement compared with…
    STAT · 7d agoNegative readoutNegative↗ source
  • House set to vote on stopgap bill that could block White House plan to politicize NIH grants
    Congressional leaders are preparing to vote on a Senate stopgap funding bill that would temporarily block the White House's proposal to place political appointees in charge of NIH research grants.…
    STAT · 7d agoRegulatoryPositive↗ source
  • Arsenal Biosciences cuts 99 jobs as it pivots to in-vivo CAR-T therapy
    Arsenal Biosciences announced a major restructuring, laying off 99 employees, which represents the majority of its workforce across all teams and locations. The company is ending development of it…
    Fierce Biotech · 7d agoLayoffsNegative↗ source
  • Alumis' lupus trial misses endpoints, but company eyes phase 3 in IFNGS‑high subgroup
    Alumis reported that its phase 2b study of the TYK2 inhibitor envudeucitinib failed to meet both the primary and secondary efficacy endpoints in patients with moderate to severe systemic lupus eryt…
    Fierce Biotech · 7d agoNegative readoutNegative↗ source
  • Novocure cyberattack exposes data of over 1,400 U.S. patients and staff
    Novocure disclosed a cyberattack in an SEC filing, saying unauthorized access to some information systems was discovered in mid‑August. The breach exposed internal patient ID numbers for more than…
    Fierce Biotech · 7d agoNegative↗ source
  • Opinion: Trump administration’s paperwork surge hampers science and health care
    The opinion piece argues that the Trump administration has expanded paperwork requirements, making it harder for scientists and Medicaid recipients to access services. Citing a federal estimate th…
    STAT · 7d agoNegative↗ source
  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 7d agoRegulatoryNeutral↗ source
  • FDA urges validation of digital health endpoints and clear missing-data plans
    FDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…
    raps · 7d agoRegulatoryNeutral↗ source
  • Trump unveils pricing agreements with midsize biotech firms; Novartis halts CAR-T trial after patient deaths
    The White House announced that President Trump has struck new pricing agreements with a group of midsize biotechnology companies, aiming to adjust drug costs. Novartis disclosed that it is pausing…
    raps · 7d agoDealNeutral↗ source
  • House passes stopgap bill to block White House plan for political control of federal research grants
    The House approved a temporary funding measure that blocks a White House proposal to let political appointees oversee federal research grants. The measure passed 370‑48 and mirrors a Senate bill p…
    STAT · 6d agoRegulatoryNeutral↗ source
  • Absci CEO envisions AI-driven, consumer-focused drug platform, eyeing hair loss, endometriosis and future GLP-1 combos
    Absci, an AI‑focused biotech founded about 15 years ago in Vancouver, Washington, is led by CEO Sean McClain, who likens his ambition for the company to creating the Apple of biotech. The surge in…
    Fierce Biotech · 6d agoPositive↗ source
  • NIH proposes cap on individual research grants, drawing mixed reactions
    The National Institutes of Health has floated a plan to limit the number of active research grants any single scientist can hold. The proposal is part of the agency’s effort to balance its research…
    STAT · 7d agoRegulatoryNeutral↗ source
  • ADA internal review rejects claims of silencing protest after member expulsions
    An internal review by the American Diabetes Association examined the removal of five participants from its scientific sessions in New Orleans. The expulsions occurred after the individuals distribu…
    STAT · 6d agoNeutral↗ source
  • ADA reviews June conference disruptions, finds no censorship of editorial
    American Diabetes Association CEO Charles "Chuck" Henderson apologized after several attendees were removed from the June 5 Scientific Sessions in New Orleans for repeated disruptions. He said the…
    STAT · 6d agoNeutral↗ source