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1,113 stories matching this filter · ← front page

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  • 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.
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STAT · 11d ago
↗ source
  • STAT+: MDCalc is scoring the clinical calculators used by millions of doctors
    MDCalc is launching a quality-rating system for the more than 800 clinical calculators used to assess disease risk, transplant eligibility, and more.
    STAT · 11d ago↗ source
  • Why affirming trans identities can be critical for suicide prevention counseling
    Advocates worry that excluding trans youth in some way from LGBTQ+ counseling services provided through the 988 crisis line could be harmful.
    STAT · 11d ago↗ source
  • Experts: Ending adequate provision would shut down prescription drug ads
    <p>The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the…
    raps · 11d ago↗ source
  • Industry wants more clarity on NGS for assessing gene therapy safety
    <p>The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products.…
    raps · 11d ago↗ source
  • This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more
    <p>Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This…
    raps · 11d ago↗ source
  • STAT+: Fresh turmoil roils American Diabetes Association following controversy at conference
    Turmoil at the ADA has taken a fresh turn, with leaders blocking editors at its flagship journal from publishing pieces detailing a controversy at the group’s annual meeting.
    STAT · 11d ago↗ source
  • Predicting biotech clinical trials and a new Alzheimer’s drug controversy
    This week on "The Readout LOUD" podcast: a new Alzheimer's drug controversy and prediction markets for clinical trials and FDA drug reviews. Listen now.
    STAT · 11d ago↗ source
  • STAT+: GOP blocks effort to end Medicare test of AI prior authorization
    The Trump administration is testing the use of AI in Medicare to approve some medical services.
    STAT · 11d ago↗ source
  • STAT+: Despite earnings celebration, UnitedHealth signals more financial pain for employers
    Insurance giant UnitedHealth signals the cost of providing workers with health insurance will climb even higher.
    STAT · 11d ago↗ source
  • Pete Hegseth’s announcement of annual testosterone screenings for service members divides medical experts
    Medical experts are divided on Defense Secretary Pete Hegseth’s announcement that U.S. service members will undergo annual testosterone screenings.
    STAT · 11d ago↗ source
  • WHO: Uganda is silent on updates following disclosure of Marburg outbreak
    The government of Uganda has gone quiet on an outbreak of the deadly Marburg virus that it reported late last month, the WHO acknowledged.
    STAT · 11d ago↗ source
  • Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics
    <figure><div><img src="https://imgproxy.divecdn.com/tzaRDX3CbhReY4UgPVj2iCgN5MzQ9V_AQf0Jo1lvCvY/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy05OTEzMjk1ODQuanBn.…
    BioPharma Dive · 11d ago↗ source
  • Veradermics keeps ‘momentum going’ as baldness drug helps women with hair loss
    <figure><div><img src="https://imgproxy.divecdn.com/1t2735bLf2pFiAc5XoslOwKIkl5O8g-p7viDbIw1C94/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMjA2NDE3NzE0LmpwZ…
    BioPharma Dive · 11d ago↗ source
  • STAT+: Brain implant restores the sensation of touch in a person with quadriplegia
    A brain-computer interface helped restore movement and sensation in a 48-year old man with quadriplegia, researchers say.
    STAT · 11d ago↗ source
  • STAT+: Medicare wants to shake up how it pays for clinical AI
    In this edition of STAT Health Tech: Centers for Medicare and Medicaid Services proposes major changes to RPM, clinical AI payment models.
    STAT · 11d ago↗ source
  • FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturers
    The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversigh…
    BioSpace · 11d ago↗ source
  • Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeover
    With the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry.
    BioSpace · 11d ago↗ source
  • Merck wins first approval of a PCSK9 cholesterol pill
    <figure><div><img src="https://imgproxy.divecdn.com/fBH5yVoS6G-IUV5sTGP2zy7wuLAX60VYZCXs0QOEVRo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9TY3JlZW5zaG90XzIwMjItMDctMjRfMS40M…
    BioPharma Dive · 11d ago↗ source
  • Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor
    Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.
    BioSpace · 11d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Kalshi bets on clinical trials, a Merck cholesterol pill, and more
    Kalshi, one of the world’s largest prediction market exchanges, plans to take bets on clinical trials and regulatory approvals
    STAT · 11d ago↗ source
  • STAT+: FDA approves Merck’s oral PCSK9 drug, a first
    Kalshi allows bets on clinical trial outcomes, Eli Lilly buys a psychedelic medicine, and more biotech news from The Readout
    STAT · 11d ago↗ source
  • Braveheart, Attovia, Vogenx keep IPOs ballooning with plans to compete in cardiometabolic, immuno
    Braveheart Bio is looking to take on Bristol Myers Squibb in hypertrophic cardiomyopathy, while Attovia Therapeutics wants to challenge Sanofi and Regeneron’s Dupixent. Vogenx, meanwhile, is lookin…
    BioSpace · 11d ago↗ source