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2,736 stories matching this filter · ← front page

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  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 14d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 14d agoApprovalNeutral↗ source
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  • Manufacturing hurdles grow as next-gen protein therapeutics gain traction
    Cytiva's sponsored piece highlights growing interest in next-generation protein-based drugs such as antibody-drug conjugates, multispecific antibodies, fragments and synthetic peptides. These moda…
    BioPharma Dive · 14d agoNeutral↗ source
  • NIH launches vaccine injury center that will also study long-term post-infection symptoms
    NIH announced a new center dedicated to investigating vaccine injuries. The center's mandate expands to include research on persistent symptoms after infections, such as long Covid. Officials sai…
    STAT · 14d agoRegulatoryNeutral↗ source
  • HHS rolls back 14 security and privacy requirements for EHR certification
    The U.S. Department of Health and Human Services issued a final rule that removes 14 of the 60 criteria used to certify electronic health record (EHR) systems. The revisions affect security, priva…
    STAT · 14d agoRegulatoryNeutral↗ source
  • First human case of cow-associated Shamonda virus reported in France
    French health officials have confirmed that a person in France has become infected with the Shamonda virus, a pathogen that previously was known to affect cattle. The World Health Organization has…
    STAT · 14d agoNeutral↗ source
  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 14d agoRegulatoryNeutral↗ source
  • Patient feels exhausted despite normal labs, highlighting stress and lifestyle factors
    A family nurse practitioner recounts a visit with a 43-year-old patient who complains that she no longer has the energy she had in her twenties. The doctor notes that all of the patient’s lab resu…
    STAT · 14d agoNegative↗ source
  • Researchers warn long-term AI use may foster social isolation, call for better data access
    An opinion piece by Cornell researchers raises the possibility that extended interaction with chatbots could gradually erode social connections, urging the scientific community to investigate this…
    STAT · 14d agoNegative↗ source
  • BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study
    The companies said the findings suggest the treatment has a “limited” impact in HER2-low breast cancer, an area where AstraZeneca and Daiichi Sankyo’s Enhertu has already set a high bar.
    BioPharma Dive · 14d ago↗ source
  • STAT+: Pharmalittle: We’re reading about a Roche lung cancer drug, a Bristol CAR-T trial death, and more
    Bristol Myers Squibb reported that one patient died after receiving its investigational CAR-T therapy in an early autoimmune trial
    STAT · 14d ago↗ source
  • Merck and Moderna’s mRNA melanoma vaccine cuts recurrence risk by 42% in Phase 3 trial
    A Phase 3 study of a personalized mRNA vaccine for melanoma, developed by Merck and Moderna, showed a substantial improvement in patient outcomes. Patients receiving the vaccine together with Merc…
    STAT · 15d agoPositive readoutPositive↗ source
  • AstraZeneca highlights broad oncology portfolio at ESMO conference
    At the European Society for Medical Oncology (ESMO) meeting in Madrid, AstraZeneca used the platform to showcase its cancer research. The company presented data on both established medicines and n…
    STAT · 15d agoPositive↗ source
  • Amgen and AstraZeneca present new combo data for extensive-stage small cell lung cancer at ESMO
    Day two of the European Society for Medical Oncology meeting in Madrid saw nearly 40,000 attendees gathering for the latest cancer research updates, as reported in the STAT+ newsletter. The sessio…
    STAT · 16d agoPositive readoutNeutral↗ source
  • Christina Applegate’s misdiagnosis highlights ongoing challenges in multiple sclerosis diagnosis
    Actor Christina Applegate, who was diagnosed with multiple sclerosis five years ago, recently disclosed that she was initially misdiagnosed. Her public story puts a human face on the difficulty doc…
    STAT · 16d agoNeutral↗ source
  • Opinion reflects on Theranos failures and the impracticality of its testing model
    The piece appears in STAT’s First Opinion section and is authored by Torie Bosch, who invites readers to submit letters of response to opinion essays. Bosch highlights a letter from Tyler Shultz,…
    STAT · 16d agoNeutral↗ source
  • Patient dies in Bristol Myers Squibb autoimmune CAR-T trial, raising safety concerns
    Bristol Myers Squibb reported that a participant in its Phase 1 CAR-T study for multiple sclerosis died. The trial was testing an investigational CAR-T therapy aimed at autoimmune disease. The pat…
    STAT · 17d agoNegative readoutNegative↗ source
  • Tango Therapeutics reports 82% tumor response in combo trial for advanced pancreatic cancer
    Tango Therapeutics and Revolution Medicines presented data showing that their experimental combination therapy produced tumor responses in 82% of patients with a specific form of advanced pancreati…
    STAT · 17d agoPositive readoutPositive↗ source
  • Tango’s pancreatic cancer combo shows striking promise at ESMO, building on Revolution Medicines’ earlier success
    Tango presented new data on its pancreatic cancer combination at the opening of the ESMO conference, highlighting a striking level of activity that builds on earlier success reported by Revolution…
    STAT · 17d agoPositive readoutPositive↗ source
  • Personalized mRNA vaccine cuts melanoma recurrence risk by 42% in trial
    A recent study of a personalized mRNA cancer vaccine showed a 42% reduction in disease recurrence for patients with melanoma compared with the standard of care. The vaccine is tailored to each pat…
    STAT · 17d agoPositive readoutPositive↗ source
  • AI drug developer Pathos secures $237 million Series E, valuation hits $3 billion
    Pathos announced a $237 million Series E round led by Bristol Myers Squibb, lifting its valuation to about $3 billion. The funding will support expansion beyond oncology into neurology, leveraging…
    STAT · 17d agoDealPositive↗ source
  • Lycia Therapeutics raises $318 million in IPO to fund protein degrader programs
    Lycia Therapeutics, a biotech focused on protein-degrading medicines, priced its initial public offering at about $318 million. The proceeds will be used to advance three LYTAC drug candidates, in…
    BioPharma Dive · 17d agoDealPositive↗ source
  • Few European-approved cancer drugs deliver high clinical benefit, analysis shows
    A new analysis of European regulator approvals between Jan 2022 and July 2026 finds that most newly approved cancer medicines provide limited clinical benefit. Out of 97 approved indications acros…
    STAT · 17d agoRegulatoryNegative↗ source
  • Novartis MS drug remibrutinib cuts relapse rates by about a third in Phase 3 trials
    Data presented at an MS conference in Toronto showed that Novartis' experimental therapy, remibrutinib, reduced the annualized relapse rate in relapsing‑remitting multiple sclerosis by roughly 35%…
    STAT · 17d agoPositive readoutPositive↗ source
  • RNAi developers see surge in IPOs and funding as industry interest revives
    BioPharma Dive’s latest data‑visualization series highlights a rapid rise in interest and investment for companies developing RNA interference (RNAi) medicines. After a years‑long lull, more than…
    BioPharma Dive · 17d agoPositive↗ source