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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 · 5d ago↗ source
  • Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5B
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 5d ago↗ source
  • Asia-Pacific Roundup: TGA seeks feedback on Australian regulations for digital mental health tools
    <p>Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to inform changes to the regulatory framework for digital mental health tools (DMHTs).</p>
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raps · 5d ago
↗ source
  • Study: China outpaces the US in cancer approvals, lags behind on first approvals
    <p>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…
    raps · 5d ago↗ source
  • MHRA touts uptick in approvals in 2025-2026 annual report
    <p>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…
    raps · 5d ago↗ source
  • Latigo preps IPO to fund non-opioid pain drug rival to Vertex’s Journax
    Latigo Biotherapeutics is preparing to go public in order to bankroll the development of its clinical-stage pipeline of non-opioid pain management drugs.
    Fierce Biotech · 6d ago↗ source
  • Geopolitics ‘chills’ British biotech IPO plans, despite $2B in Q2 VC funds
    Geopolitical uncertainty has continued to “chill” IPO sentiment among British biotechs, an industry leader has told Fierce, even as the sector saw second-quarter venture capital funding reach a fiv…
    Fierce Biotech · 6d ago↗ source
  • Abbott hit by cyberattack on cancer diagnostics, LabCentral portal businesses
    Abbott has been struck by several cyberattacks which targeted the medtech giant’s cancer diagnostics and LabCentral businesses. <br>
    Fierce Biotech · 6d 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 · 6d ago↗ source
  • Biogen’s mixed Alzheimer’s data; Two new startups launch; and more
    Welcome back to another edition of Endpoints Weekly! We hope you all have been staying safe indoors as the Canadian wildfires blanketed much of the US Northeast this week. Hopefully things calm dow…
    Endpoints · 7d ago↗ source
  • ‘A rising tide scenario’: Why other Big Pharmas could follow Lilly into psychedelics
    After Eli Lilly dived into the psychedelics space with a $2.8 billion upfront acquisition of AtaiBeckley last week, industry experts told Fierce that the deal would give the space added momentum.
    Fierce Biotech · 7d 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 · 7d 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 · 7d ago↗ source
  • Midsized biotechs press White House to drop CMS pricing rules
    A number of midsized biotech companies have met with White House and HHS officials in the last week, presenting their case for why two pending CMS pricing models could hinder their business and sho…
    Endpoints · 8d ago↗ source
  • Celcuity got its cancer drug approved. Then its stock dipped
    The FDA’s approval for Celcuity’s cancer drug Revtorpyk on Tuesday was widely anticipated. What Wall Street didn’t expect was that the drug could take until the end of the quarter to launch. ...
    Endpoints · 8d 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 · 8d 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 · 8d 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 · 8d ago↗ source
  • GSK plans large study to see if shingles vaccine can prevent dementia
    LONDON — Over the past several years, data scientists searching through national health records have noticed something surprising about people who had been vaccinated for shingles: They were less l…
    Endpoints · 8d ago↗ source
  • Dimerix buys a kidney injury drug; Arpeggio appears to be winding down
    Plus, news about Takeda, Novartis and Regenxbio. 🤝 Mission sells kidney injury drug to Dimerix: Dimerix will pay $5 million upfront for Mission’s Phase 2-ready candidate for acute kidney injury,…
    Endpoints · 8d 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 · 8d ago↗ source
  • Updated: BlossomHill and Latigo join flourishing IPO queue with cancer, pain drugs
    Last summer, zero biotechs made it onto the public markets as the industry weathered a seven-month dry spell for initial share sales. This time around, it's a summer IPO party as six
    Endpoints · 8d 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 · 8d 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 · 8d 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 · 8d ago↗ source