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3,273 stories matching this filter · ← front page

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  • Former GOP lawmakers warn that confusing vaccine messaging could hurt party's midterm prospects
    Two former Republican congressmen say the party's mixed messaging on vaccines has become a political liability. They argue that the lack of a clear stance could alienate voters and damage Republic…
    STAT · 22h agoNegative↗ source
  • Measles resurgence threatens Republican midterm prospects, physicians warn
    Physicians and former Republican congressmen Larry Bucshon and Michael C. Burgess wrote an opinion piece warning that the recent measles surge is turning into a political liability for the GOP. Va…
    STAT · 1d agoNegative↗ source
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Japan’s PMDA releases guidance on evaluating generative AI-enabled medical devices
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of review points aimed at medical devices that incorporate generative artificial intelligence. The guidance outlines th…
raps · 1d agoRegulatoryNeutral↗ source
  • Philips issues updated use instructions for Lumify ultrasound systems after software glitch risk
    Philips Ultrasound has sent a letter to customers of its Lumify diagnostic ultrasound system, advising that the devices require updated use instructions. The update addresses a software applicatio…
    fda medwatch · 1d agoCRLNegative↗ source
  • MedTech firms grow more comfortable with FDA's Quality Management System Regulation amid inspection concerns
    At The MedTech Conference in Boston, a senior industry executive reported that the medtech sector is gradually accepting the new Quality Management System Regulation (QMSR) despite early worries.…
    raps · 1d agoRegulatoryNeutral↗ source
  • Editor shares personal loss and calls for assisted suicide options for severe mental illness
    Torie Bosch, an editor at STAT, recounts the repeated suicide attempts of her mother, culminating in her death in 2016. She describes the ongoing cycle of crises, hospitalizations and the emotional…
    STAT · 1d agoNegative↗ source
  • Theranos whistleblower says new film ‘You Can See Everything’ is art, not a documentary
    Tyler Shultz, a former Theranos scientist who became a whistleblower, wrote an opinion piece criticizing Nathan Fielder’s recent film about Elizabeth Holmes. He argues the movie, titled “You Can S…
    STAT · 18h agoNegative↗ source
  • Cambridge biologist David Sabatini awarded $6 million after jury rejects harassment claims
    David Sabatini, a former MIT and Whitehead Institute researcher, faced allegations of inappropriate conduct from a younger colleague, leading to his removal from the institute. A Suffolk County ju…
    STAT · 1d agoPositive↗ source
  • AbbVie’s Skyrizi combo beats Skyrizi alone in mid-stage Crohn’s trial
    AbbVie’s Skyrizi-based combination therapy for inflammatory bowel disease worked better than Skyrizi alone in a mid-stage trial in Crohn’s disease, the company said Monday. The new product is coden…
    Endpoints · 23h ago↗ source
  • Endpoints Weekly highlights search for Alzheimer’s ‘statin’, Arrowhead’s tau-lowering injectable and AI Day recap
    Endpoints Weekly released its latest edition, previewing several biotech stories including a quest for a “statin of Alzheimer’s” and new data on Arrowhead’s injectable therapy that reduces tau prot…
    Endpoints · 3d agoNeutral↗ source
  • Jury awards $6 million to former MIT professor David Sabatini in defamation case
    A Suffolk County jury awarded $6 million in damages to former MIT professor David Sabatini after finding the plaintiff's claims were defamatory. The case stemmed from accusations by a younger coll…
    STAT · 3d agoPositive↗ source
  • Revolution Medicines' pancreatic cancer therapy Rasonque moves closer to European approval after FDA clearance
    Revolution Medicines' experimental drug Rasonque, aimed at treating pancreatic cancer, has received a recommendation for approval from European regulators. The recommendation follows an earlier po…
    STAT · 3d agoApprovalPositive↗ source
  • Hospitals Turn to Longevity Clinics as New Revenue Stream
    STAT's biotech podcast "The Readout LOUD" featured a discussion about the rapid growth of longevity clinics that are being opened by hospitals. Reporters noted that the longevity medicine market i…
    STAT · 3d agoNeutral↗ source
  • City Therapeutics raises $200 million in IPO, becoming 26th biotech listing of 2026
    City Therapeutics announced that it has completed a $200 million initial public offering, making it the 26th biotech to go public in 2026. The company, based in Kendall Square, will begin trading…
    Endpoints · 4d agoDealPositive↗ source
  • FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groups
    The FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practice requirements, citing problems with ensuring product sterility and meeting sp…
    raps · 4d agoRegulatoryNegative↗ source
  • Novartis ends mid-stage Fabhalta trial in lupus nephritis citing strategic considerations
    Novartis has terminated its mid-stage trial of Fabhalta (iptacopan) in patients with lupus nephritis, according to a federal clinical trials registry. The company said the decision was driven by s…
    Endpoints · 3d agoCRLNegative↗ source
  • EU regulators endorse Eli Lilly’s oral GLP-1 pill orforglipron
    The European Medicines Agency’s human medicines committee (CHMP) has given a positive opinion on Eli Lilly’s oral GLP-1 medication, orforglipron, providing the drug with EU regulatory backing. The…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • FDA issues warning letters to drug makers and a lab over CGMP and GLP violations
    FDA sent warning letters to several drug manufacturers for not meeting current good manufacturing practice (CGMP) requirements. The letters point to issues such as ensuring final product sterility…
    raps · 4d agoRegulatoryNegative↗ source
  • Sanofi appoints former Roche exec Paulo Fontoura as global R&D head, eyes AI and dealmaking
    Sanofi announced that Paulo Fontoura, who spent 16 years at Roche and most recently worked at AI drug discovery startup Xaira Therapeutics, has become the company’s global head of R&D as of Septemb…
    Endpoints · 3d agoNeutral↗ source
  • China moves to ban export of select biotech platforms while keeping drug licensing open
    Chinese Ministry of Commerce announced it is pursuing an export ban on certain biotechnology platforms. The measure is intended to restrict the types of deals domestic companies can make abroad, r…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • HHS moves to let compounding pharmacies make select peptides as China tightens biotech exports but permits foreign licensing
    The HHS announced a policy that would allow compounding pharmacies to produce certain peptide drugs, expanding access and potentially lowering costs. The move is part of the Trump administration's…
    STAT · 3d agoRegulatoryNeutral↗ source
  • FDA reviews interim access policy for compounded peptides as Enspryng label expands
    The U.S. Department of Health and Human Services and the Food and Drug Administration have drafted a new interim access policy that would allow compounding pharmacies to use certain peptide drugs u…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • Eli Lilly signals interest in researching and improving psychedelic ibogaine, says neuroscience chief
    At a recent psychedelics conference, Eli Lilly’s neuroscience president Carole Ho announced the company’s interest in studying ibogaine. Ho said Lilly aims to improve the drug’s safety and efficac…
    Endpoints · 3d agoPositive↗ source
  • Study shows clinicians increasingly turn to AI for medical queries despite limited evidence of impact
    New research examined usage data from OpenEvidence, an AI search platform, to track how clinicians use AI to answer medical questions. Findings show a rapid increase in the frequency of AI queries…
    Endpoints · 3d agoNeutral↗ source
  • Former Genentech researcher Lélia Delamarre appointed head of R&D at Medici Therapeutics; Intellia hires Scholar Rock CMO
    Lélia Delamarre, a former senior scientist at Genentech, announced on LinkedIn that she will lead research and development at Medici Therapeutics, a cancer‑focused biotech backed by ARCH venture pa…
    Endpoints · 4d agoNeutral↗ source