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1,894 stories matching this filter · ← front page

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  • 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
  • Mirador unveils part of pipeline with drug from Kira to rival Tavneos
    Mirador Therapeutics, the secretive immune disease biotech with more than $650 million in VC funding, is finally revealing a piece of its pipeline. The San Diego biotech said Thursday it reached…
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Endpoints · 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 · 12d 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 · 12d 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 · 12d ago↗ source
  • What health system execs are talking about
    Earlier this week, I swung by the American Hospital Association’s Leadership Summit in downtown Denver. When I wasn’t giving out ice cream recommendations, I was trying to get a sense of what hos…
    Endpoints · 12d 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 · 12d ago↗ source
  • Kelun pads efficacy profile of Merck-partnered ADC; Europe will have to wait for Boehringer's Hernexeos
    Plus, news about Vogenx and Orakl Oncology. 🇨🇳 Kelun touts China data for sac-TMT: Kelun-Biotech announced on Tuesday that its Merck-partnered antibody-drug conjugate sacituzumab tirumotecan su…
    Endpoints · 12d 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 · 12d ago↗ source
  • Q&A: Betty Tijms wants to stop treating Alzheimer’s as a single disease
    LONDON — For more than a century, scientists studying Alzheimer’s have largely focused their efforts on two proteins — amyloid and tau — that clearly accumulate in the disease. But not everyone wit…
    Endpoints · 12d 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 · 12d ago↗ source
  • US drug shortages rise for third straight quarter, hurt by lone suppliers
    The number of drugs in shortage in the US rose for a third straight quarter, a situation complicated by the fact that almost half of the medicines in tight supply rely only on a single ...
    Endpoints · 12d 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 · 12d 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 · 12d 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 · 12d 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 · 12d 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 · 12d 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 · 12d 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 · 12d ago↗ source
  • The future of pain relief: Exploring opioid alternatives
    In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has…
    BioSpace · 12d ago↗ source