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3,873 stories matching this filter · ← front page

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  • Former MAHA official Calley Means blames White House for yielding to industry pressure
    Calley Means, a leader of the Make America Healthy Again (MAHA) group and former senior official in the Trump administration, announced his resignation and criticized the White House for being sway…
    STAT · 2d agoNegative↗ source
  • Novo and Pfizer appoint new CFOs while Alnylam sees departure of its chief commercial officer
    Novo announced the appointment of a new chief financial officer as part of its effort to improve financial leadership. The hire follows earlier reports that the company is seeking to turn a corner…
    Endpoints · 3d agoNeutral↗ source
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globenewswire health73
fda press58
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Ophthalmology996
Endocrinology & Metabolism768
Pain768
Nephrology753
Medical records often miss women's health experiences, limiting AI's potential
Ann Hirsch and Jennifer Silva argue that artificial intelligence cannot reach its full promise in women's health until medical records capture the complete picture of patients' lives. They cite a r…
STAT · 3d agoNegative↗ source
  • Medicare delays controversial remote patient monitoring ban to 2029, opening window for provider pushback
    Medicare regulators advanced a plan to prohibit hospitals and other providers from using third‑party companies for remote patient monitoring (RPM) services, despite strong opposition from health‑te…
    STAT · 3d agoRegulatoryNeutral↗ source
  • Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA work
    At the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…
    raps · 3d agoRegulatoryNeutral↗ source
  • Kratom use rises as health officials warn of addiction risk and push emergency bans
    Kratom, a plant‑derived supplement, is becoming more visible in smoke shops and gas stations, yet most Americans remain unfamiliar with the product. Health officials have highlighted the addiction…
    STAT · 3d agoRegulatoryNegative↗ source
  • Opinion: STAT+: What it’s like to live with cognitively unimpaired Alzheimer’s disease
    People with cognitively unimpaired Alzheimer’s “may be asymptomatic, but they do have a disease experience,” writes Jason Karlawish.
    STAT · 3d agoNeutral↗ source
  • Study finds ritual cannabis use in 2,800-year-old Siberian tomb
    Researchers published a paper in Science that presents archaeological evidence of cannabis being used in ritual contexts in a tomb dating back about 2,800 years in Siberia. The analysis of plant re…
    STAT · 3d agoNeutral↗ source
  • Novartis reports seven new tumor cases in children treated with Zolgensma gene therapy
    Novartis has disclosed that seven children who received its SMA gene therapy, Zolgensma, have been found to have tumors that were not previously reported. The cases were brought to light by an adv…
    STAT · 3d agoRegulatoryNegative↗ source
  • Revolution Medicines reports $198 million Q3 sales for pancreatic cancer drug Rasonque, calling it best oncology launch ever
    Revolution Medicines' new pancreatic cancer drug Rasonque generated $198 million in revenue in the third quarter, far exceeding analyst expectations of $50‑100 million. The drug received FDA appro…
    BioPharma Dive · 4d agoPositive↗ source
  • Revolution Medicines' Rasonque generates $198 million in sales within five weeks of U.S. approval
    Revolution Medicines reported that its pancreatic cancer therapy Rasonque has achieved $198 million in revenue in the first five weeks after receiving U.S. approval. The company said more than 5,00…
    STAT · 4d agoApprovalPositive↗ source
  • Medicare to slash 340B drug payments and expand site-neutral rules in 2027
    Medicare finalized a rule that will cut payments for drugs covered by the 340B discount program and broaden site-neutral payment policies beginning in 2027. The rule is expected to reduce Medicare…
    BioPharma Dive · 3d agoRegulatoryNegative↗ source
  • J&J and AbbVie present early trispecific antibody data for multiple myeloma at ASH meeting
    At the American Society of Hematology (ASH) meeting, Johnson & Johnson and AbbVie are slated to share early clinical data on trispecific antibodies targeting multiple myeloma. These next‑generation…
    BioPharma Dive · 4d agoPositive readoutPositive↗ source
  • MIT defamation verdict awards $6 million to former star scientist, sparking campus debate over harassment claims
    A Boston jury awarded former MIT biologist David Sabatini $6 million in a defamation case against former colleague Kristin Knouse, a biology professor at the institute. The judgment stems from a la…
    STAT · 3d agoNegative↗ source
  • Sickle cell gene-editing therapy shows signs of revival as developers revisit trial after earlier safety halt
    A recent STAT+ article highlights that a sickle cell gene‑editing therapy, whose trial was stopped three years ago after a serious adverse event in the first patient, may be making a comeback. The…
    STAT · 4d agoNeutral↗ source
  • RevMed stock rises on early Rasonque sales as whistleblower sues Madrigal over MASH safety
    RevMed announced its first sales figures for Rasonque, a therapy targeting pancreatic cancer, and the news sent the company's shares higher. The company said the early sales data reflect market up…
    Endpoints · 4d agoNeutral↗ source
  • Caldera and Evommune secure China licensing agreements for autoimmune drug assets
    Caldera and Evommune announced they have entered licensing agreements with Chinese partners to bring their autoimmune drug programs to the Chinese market. The deals come as the biopharma sector is…
    Endpoints · 4d agoDealPositive↗ source
  • Merck reports positive mid-stage results for Hanmi-licensed MASH drug
    Merck announced Thursday that its dual GLP-1/glucagon agonist, which it licensed from South Korea’s Hanmi Pharmaceutical in 2020, has met its primary endpoints in a mid-stage trial for metabolic dy…
    Endpoints · 4d agoPositive readoutPositive↗ source
  • India proposes rule to instantly suspend drug manufacturing licenses that fail government quality tests
    India’s regulators have drafted new rules that would require an immediate suspension of any drug manufacturing license if the product does not meet quality standards in government testing. The prop…
    STAT · 4d agoRegulatoryNeutral↗ source
  • Democrats’ midterm sweep positions Bernie Sanders to steer Senate health committee, raising hopes for major FDA reforms
    The recent midterm elections delivered a decisive victory for Democrats, giving the party control of Congress and setting the stage for sweeping health‑care changes. Among the anticipated shifts,…
    STAT · 4d agoRegulatoryNeutral↗ source
  • T-Therapeutics secures $133 million Series B to advance bispecific cancer and autoimmune drugs
    T-Therapeutics, a UK-based biotech focused on T-cell engager technology, announced a $133 million Series B financing. The capital will be used to generate proof-of-concept data for its lead bispec…
    BioPharma Dive · 4d agoDealPositive↗ source
  • China clamps down on investigator-initiated biotech trials after patient deaths, halting rare-disease studies
    Chinese regulators have introduced new rules that sharply limit investigator‑initiated biotech trials after a series of patient deaths were reported this summer. The policy shift is intended to tig…
    STAT · 4d agoRegulatoryNegative↗ source
  • Alethio Therapeutics raises $90 million Series A to develop antibody for essential thrombocythemia
    Alethio Therapeutics, a spinout from the University of Oxford, announced a $90 million Series A financing round. The capital will fund the company’s lead program, an antibody designed to treat ess…
    Endpoints · 4d agoDealPositive↗ source
  • Alethio Therapeutics secures $90 million to develop treatments for rare blood cancers
    Alethio Therapeutics, a UK based biotechnology startup, announced it has raised $90 million in new financing. The capital will be used to advance its pipeline targeting myeloproliferative neoplasm…
    BioPharma Dive · 4d agoDealPositive↗ source
  • T-Therapeutics raises $133 million from Sanofi, J&J, Merck KGaA and Eli Lilly for TCR cancer and autoimmune programs
    T-Therapeutics, a UK biotech focused on T-cell receptor therapies for cancer and autoimmune diseases, announced it has raised $133 million in financing. The round is led by Sanofi with participati…
    Endpoints · 4d agoDealPositive↗ source