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  • How Kyverna rode CAR T’s autoimmune wave to the FDA’s door
    Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
    BioSpace · 9d ago↗ source
  • Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5B
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 9d ago↗ source
  • Asia-Pacific Roundup: TGA seeks feedback on Australian regulations for digital mental health tools
    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to inform changes to the regulatory framework for digital mental health tools (DMHTs).
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raps · 9d ago
↗ source
  • Study: China outpaces the US in cancer approvals, lags behind on first approvals
    While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more fi…
    raps · 9d ago↗ source
  • MHRA touts uptick in approvals in 2025-2026 annual report
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) touted its achievements over the last year its 2025-2026 annual report to Parliament, which includes approving more new drugs tha…
    raps · 9d ago↗ source
  • Opinion: Beware the unintended consequences of testosterone screening for military servicemembers
    “I fear that the widespread rollout of testosterone screening may lead to some surprising and unintended consequences,” writes a urologist who studies testosterone.
    STAT · 10d ago↗ source
  • Opinion: STAT readers on the value of primary care, obesity as a disease, and more
    “The real opportunity is to move beyond policies and narratives that pit specialties against one another,” presidents of the AAFP, ACP, and AAP write.
    STAT · 10d ago↗ source
  • Opinion: What the 20th-century war on smog tells us about today’s wildfire smoke
    The evolution of air pollution policy shows how to respond to the dangerous haze caused by Canadian wildfires, experts write in opinion piece.
    STAT · 11d ago↗ source
  • Quitting smoking is hard. A Medicare change may push doctors to give more help
    Physicians who offer counseling on quitting cigarettes and alcohol during patient visits would get a 19% increase in reimbursement under a proposed Medicare change.
    STAT · 11d ago↗ source
  • Jasper gets a lifeline in merger with immune drugmaker Kira
    The acquisition, which involves a concurrent licensing deal with startup Mirador, gives Jasper a chance to rebound from setbacks that have wiped out most of its market value.
    BioPharma Dive · 11d ago↗ source
  • India’s life sciences sector at turning point for innovation: Report
    Structural gaps in areas including clinical execution and funding limit India’s ability to scale up innovation, according to a report from Boston Consulting Group and HealthKois.
    BioSpace · 11d ago↗ source
  • Lettuce at Taco Bell in five states confirmed as a source of diarrhea-causing parasite
    Health officials have identified lettuce from Mexico served at Taco Bell locations across five U.S. states as a source of the outbreak of diarrhea-causing parasite cyclospora.
    STAT · 11d ago↗ source
  • STAT+: The end for GSK’s chronic cough treatment
    Sonothera's ultrasound gene therapy delivery, a new Alzheimer's drug controversy, and more biotech news from The Readout
    STAT · 11d ago↗ source
  • Arbutus, Sanofi escalate mRNA patent fights; InnoCare’s TYK2 contender advances
    The new lawsuits add to a web of legal disputes over technology involved in COVID vaccines. Elsewhere, a prolific AI biotech inked another deal and Insmed strengthened support for a closely watched…
    BioPharma Dive · 11d ago↗ source
  • Compounders maintain a firm grip on the GLP-1 market
    Despite an FDA crackdown, numerous pharma lawsuits and possible safety risks, nearly 1 in 5 patients are still taking cheaper weight-loss alternatives.
    BioPharma Dive · 11d ago↗ source
  • GSK shelves cough drug acquired in $2B deal
    Mixed Phase 3 data for camlipixant prompted the British pharma to cease development, making the drug the third from its class to fail.
    BioPharma Dive · 11d ago↗ source
  • STAT+: Up and down the ladder: The latest comings and goings
    From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
    STAT · 11d ago↗ source
  • STAT+: Pharmalittle: We’re reading about rising drug shortages, GSK coughing up a trial loss, and more
    The number of active medication shortages in the U.S. rose to 227 in the second quarter of 2026
    STAT · 11d ago↗ source
  • How well are AI-discovered drugs faring in the clinic?
    Some of the industry’s most closely-watched AI drugs could provide insight into the success of technology-assisted development.
    BioPharma Dive · 11d ago↗ source
  • GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 fail
    Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.
    BioSpace · 11d ago↗ source
  • Who can access testosterone hormone medication in the U.S.?
    Wildfire smoke health hazards, a new idea for treating Duchenne, and more health news from Morning Rounds
    STAT · 11d ago↗ source
  • Insmed moves closer to $6B opportunity as PAH drug shows long-term durability
    Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements thro…
    BioSpace · 11d ago↗ source
  • FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking
    Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Ener…
    BioSpace · 11d ago↗ source
  • STAT+: Can ultrasound unlock the power of gene therapy? A startup makes big claims
    Sonothera is developing a new way to deliver genes into cells that, if borne out, could have a big impact on muscular dystrophy and other diseases.
    STAT · 11d ago↗ source
  • Opinion: MAHA is rewriting the vocabulary of American mental health care
    “‘Deprescribing’ elevated into a movement, and a cultural default, is a clinical hazard,” writes Sunny Patel.
    STAT · 11d ago↗ source