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  • 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 · 13d 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 · 13d agoNegative readoutNegative↗ source
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  • 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 · 13d agoRegulatoryPositive↗ 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 · 13d 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  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic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 · 13d 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 · 13d 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 · 13d 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 · 13d agoRegulatoryNeutral↗ 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 · 13d 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 · 12d 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 · 12d agoNeutral↗ source
  • Trial over Lindsay Clancy’s case threatens progress in postpartum psychiatry
    Opinion piece by reproductive psychiatrist Jennifer Okwerekwu notes that the ongoing Lindsay Clancy trial, in which a jury remains deadlocked after five weeks, pits a defense claim of health-care s…
    STAT · 13d agoNegative↗ source
  • Dietitian Shortage Threatens Trump Administration's Nutrition Initiatives
    The Trump administration's Make America Healthy Again (MAHA) plan has shifted nutrition guidance, promoting more protein, cutting processed foods, and revamping meals in schools, military bases and…
    STAT · 13d agoNegative↗ source
  • FDA clears Protagonist-Takeda therapy for rare blood cancer as Lilly moves to buy Merida for up to $2.88 billion
    The U.S. Food and Drug Administration has granted approval to a collaborative therapy from Protagonist and Takeda aimed at treating a rare form of blood cancer. This regulatory decision adds a new…
    raps · 14d agoDealPositive↗ source
  • FDA approves Takeda/Protagonist cancer drug Mimrylo as White House readies new drug pricing deals, BioNTech ends colon vaccine trial
    The U.S. Food and Drug Administration gave approval to a weekly injection called Mimrylo, developed by Takeda and partner Protagonist Therapeutics, for treatment of a slow‑growing cancer. The agenc…
    STAT · 14d agoApprovalNeutral↗ source
  • New American Headache Society guidelines highlight expanded migraine prevention options
    The American Headache Society and the American Academy of Neurology released updated guidance on migraine prevention, the first revision since 2012. The new recommendations note that the FDA has a…
    STAT · 14d agoRegulatoryPositive↗ source
  • Trump announces nine new drug pricing agreements to align U.S. prices with peer nations
    President Trump announced a new round of voluntary pricing agreements with nine additional pharmaceutical companies, adding to the 17 firms that have previously signed similar deals. The companies…
    STAT · 14d agoDealPositive↗ source
  • Amgen faces FTC-backed lawsuit over patent-application purchase amid insurer dispute
    Amgen and a large health insurer are locked in a court fight over whether purchasing a drug patent application can be used to extend a monopoly on a medicine. The case is drawing attention because…
    STAT · 14d agoRegulatoryNegative↗ source
  • GLP-1 drugs push employers to rethink worker health-care costs
    GLP-1 medications are prompting many employers to reexamine how they fund employee health care. Rising prescription use and associated costs are forcing companies to consider new benefit designs an…
    STAT · 14d agoNegative↗ source
  • Personalized mRNA melanoma vaccine shows clinical success, reviving optimism for the platform
    Moderna and Merck reported positive results from a personalized mRNA vaccine designed to treat melanoma in a recent clinical study. The outcome is being hailed as a boost for mRNA technology, whic…
    STAT · 14d agoPositive readoutPositive↗ source
  • Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance
    A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders. Indu…
    raps · 14d agoRegulatoryNeutral↗ source
  • Radiopharmaceutical experts urge pharma to adopt bolder dosing despite safety concerns
    Louise Emmett and a group of radiopharmaceutical specialists argue that these modern radiation‑based drugs could dramatically improve cancer outcomes if used more aggressively. They say the therapi…
    STAT · 14d agoNeutral↗ source
  • Pregnancy hormone explored as possible guide for cardiovascular drug development
    The STAT+ newsletter preview highlights a discussion about whether a hormone that regulates pregnancy could be leveraged to direct a new cardiovascular therapy. The piece also notes that researche…
    STAT · 14d agoNeutral↗ source
  • Industry and patient groups urge FDA to revise master protocol guidance
    Industry groups and patient advocacy organizations have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for…
    raps · 14d agoRegulatoryNeutral↗ source
  • Highlights from the European Society of Cardiology meeting and updates on radiopharmaceutical research
    The newsletter reports that the European Society of Cardiology convened in Munich, with Europe correspondent Andrew Joseph providing coverage of the event. The author contrasts the ESC’s rotating…
    STAT · 14d agoNeutral↗ source