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1,855 stories matching this filter · ← front page

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  • CDER plans new guidance on AI, electronic safety report submissions, and more
    <p>The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four…
    raps · 11d ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    <p>Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure a…
    raps · 11d ago↗ source
  • Graham’s death from aortic dissection raises questions about preventing the rare disorder
    When the body’s most important blood vessel tears from the inside, it’s a medical emergency that can be years in the making.
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STAT · 11d ago
↗ source
  • Graham’s death from aortic dissection raises questions about preventing the rare disorder
    When the body’s most important blood vessel tears from the inside, it’s a medical emergency that can be years in the making.
    STAT · 11d ago↗ source
  • STAT+: At key hearing, Kennedy’s ouster of former CDC director looms over nominee to replace her
    Erica Schwartz and Sean Kaufman navigated tough questions about vaccines, political independence, and pushing back on RFK Jr.
    STAT · 11d ago↗ source
  • FDA acting chief walks back Makary's practice of policymaking through journals
    The FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy. The about-face…
    Endpoints · 11d ago↗ source
  • Senate committee questions CDC pick on political interference over vaccines
    Lawmakers in the Senate pressed the Trump administration’s nominee for CDC director on whether she will cave to political pressure during a confirmation hearing on Wednesday. The CDC has been wit…
    Endpoints · 11d ago↗ source
  • STAT+: New study untangles how Epstein-Barr viral infection triggers immune response in multiple sclerosis
    A new study claims to have uncovered how Epstein-Barr virus launches immune responses seen in people with multiple sclerosis. 
    STAT · 11d ago↗ source
  • STAT+: Improvements in Alzheimer’s testing could make diagnostics more accessible, informative
    Alzheimer's research is moving in new directions, finding ways to make testing much more accessible, and offering more nuanced results.
    STAT · 11d ago↗ source
  • Cassidy grills Trump nominee on past vaccine comments in heated exchange
    Sean Kaufman, Trump's pick for a key pandemic preparedness role, has questioned vaccines and criticized the CDC.
    STAT · 11d ago↗ source
  • Amid $55B US manufacturing push, J&J turns to streamlining its pharma supply chain
    After committing $55 billion last year to bolster U.S. manufacturing capabilities, Johnson & Johnson is making changes to its pharmaceutical supply chain.
    BioSpace · 11d ago↗ source
  • STAT+: Bipartisan lawmakers want to require U.S. to probe reliance on foreign-made drugs, ingredients
    A trio of bipartisan lawmakers reintroduced a bill requiring the FTC and Treasury to investigate whether the U.S. relies too heavily on foreign countries as part of its pharmaceutical supply…
    STAT · 11d ago↗ source
  • STAT+: Elevance plots a Medicaid retreat as costs remain high
    Elevance Health, the country’s second-biggest health insurer, said it plans to further shrink its Medicaid portfolio in the coming year, just as states roll out work requirements.
    STAT · 11d ago↗ source
  • J&J restructures pharma manufacturing footprint at cost of up to $750M
    Johnson & Johnson is anticipating as much as $750 million in costs to restructure its pharmaceutical supply chain and exit factories, moves that are coming as it pushes ahead with its $55 billi…
    Endpoints · 11d ago↗ source
  • Eli Lilly invests in Oura to support patients on GLP-1 drugs
    Eli Lilly on Wednesday made an equity investment in wearable ring startup Oura as the drugmaker looks for ways to support patients taking its GLP-1 medications. An Oura spokesperson declined to s…
    Endpoints · 11d ago↗ source
  • STAT+: The whistleblower, The Lab, and the fine print
    In this AI Prognosis news roundup: Mayo's AI whistleblower, Sutter Health's reply to lawsuit over Abridge scribe, and more.
    STAT · 11d ago↗ source
  • STAT+: Glenmark to pay $29.6 million to settle price-fixing allegations in long-running battle with states
    Glenmark Pharmaceuticals agreed to pay $29.6 million to settle price-fixing allegations in a long-running battle with dozens of states.
    STAT · 12d ago↗ source
  • Celcuity gains FDA approval for closely watched breast cancer drug
    <figure><div><img src="https://imgproxy.divecdn.com/f5a4VRDXQg-SwH2yBDKHbtLeyVHpX8cemnSbe-t-6xU/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjI3NzEwNDk4X0F5Q…
    BioPharma Dive · 12d ago↗ source
  • STAT+: In a major policy shift, Medicare proposes to ban vendors from providing remote monitoring services
    Medicare is proposing to ban vendors from providing remote patient monitoring services on behalf of doctors.
    STAT · 12d ago↗ source
  • Merck ADC, in China study, shows potential to replace chemo in lung cancer
    <figure><div><img src="https://imgproxy.divecdn.com/lM3CYabLlmazQYt-COfrxYzxdsO20VnU3PS1vfCq2lE/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjEwOTMxMjkxXzEua…
    BioPharma Dive · 12d ago↗ source
  • Braveheart, Attovia join next wave of biotech IPOs
    <figure><div><img src="https://imgproxy.divecdn.com/Z8dYUynyAGfRpaERds4uqJPo8FGtQPXgqxIr2sImOmo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDUxMTE2NzE0LmpwZ…
    BioPharma Dive · 12d ago↗ source
  • Radiopharma maker AdvanCell hauls in $315M for Pluvicto challenger
    AdvanCell raised a $315 million Series D to study a lead-based prostate cancer agent and shore up its US manufacturing of the radioactive treatment. The round marks one of the largest yet for a r…
    Endpoints · 12d ago↗ source
  • STAT+: Celcuity’s breast cancer drug approved, its first
    FDA's new CBER chief promises normalcy, an weight loss drug without GLP-1s, and more biotech news from The Readout
    STAT · 12d ago↗ source
  • Deaths from coronary artery disease have fallen, but more progress is within reach
    Managing risk factors is the key to further progress in reducing deaths from coronary artery disease, a new study finds.
    STAT · 12d ago↗ source
  • Kelun’s Merck-partnered ADC notches late-stage NSCLC win alongside Keytruda
    The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Par…
    BioSpace · 12d ago↗ source