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515 stories matching this filter · ← front page

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  • Boston ER doctor Jeremy Faust grows influence with Inside Medicine newsletter
    Jeremy Faust works as an emergency physician at Brigham and Women's Hospital in Boston, handling busy shifts and caring for dozens of patients. In addition to his clinical duties, Faust runs the S…
    STAT · 3mo agoPositive↗ source
  • AstraZeneca and Ionis see pivotal trial miss for ATTR-CM drug Wainua
    AstraZeneca announced that its experimental therapy Wainua, developed with Ionis, failed to meet primary endpoints in a pivotal study for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). T…
    STAT · 3mo agoNegative readoutNegative↗ source
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  • Father spends $70 million on gene therapy trial for daughter with ultra-rare disease, faces FDA hurdles
    Matt Wilsey has spent a decade and about $70 million trying to develop a gene therapy for his 15-year-old daughter Grace, who suffers from a fatal ultra-rare disease. His personal quest has turned…
    STAT · 3mo agoNegative↗ source
  • HHS proposes new rule to compensate Covid-19 vaccine injury claims
    The U.S. Department of Health and Human Services has issued a proposed rule that would create a compensation mechanism for people who say they were injured by Covid-19 vaccines. The new system is…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • ARPA-H launches $160 million THRIVE program to fund seven labs developing custom gene-editing therapies for rare diseases
    ARPA-H, the U.S. Advanced Research Projects Agency for Health, announced a new initiative called THRIVE with up to $160 million in funding. The program will support seven research teams over five…
    STAT · 3mo agoPositive↗ source
  • Prime Secures Arbitration Victory Over Beam, Paving Way for Clinical Trials
    Prime, a biotech firm developing a gene‑therapy candidate, won an arbitration case against Beam Therapeutics. The ruling removes a legal hurdle and allows Prime to advance its program into clinical…
    STAT · 3mo agoRegulatoryPositive↗ source
  • AstraZeneca/Ionis heart-failure drug Wainua fails pivotal trial as White House reviews FDA commissioner candidates
    The White House is reviewing a shortlist of three candidates for the FDA commissioner position, according to STAT. The list includes White House adviser Heidi Overton, oncologist and health‑system…
    STAT · 3mo agoNegative readoutNegative↗ source
  • Father invests $70 million in gene therapy quest for daughter with ultra‑rare NGLY1 deficiency, faces FDA scrutiny
    Matt Wilsey has spent a decade and roughly $70 million trying to develop a gene therapy for his daughter Grace, who suffers from NGLY1 deficiency, an ultra‑rare genetic disorder. NGLY1 deficiency…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Sanofi proposes to cease negative statements about CSL's flu vaccine amid EU probe
    Sanofi has offered to stop making disparaging comments about CSL's flu vaccine following an investigation launched by the European Commission. The offer comes two weeks after the Commission began p…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • RFK Jr. moves to compile list of Covid-19 vaccine injuries to streamline compensation claims
    Health secretary Robert F. Kennedy Jr. announced plans to create a list of injuries that would be presumed caused by Covid-19 vaccines. The list would allow individuals who suffer from those condi…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Ebola outbreak in eastern DRC risks becoming a never-ending crisis, experts warn
    Ivan Buendia Gayton, a technologist and humanitarian adviser, and Eric D. Perakslis, an engineer and former MSF strategic adviser, co‑author an opinion piece on the latest Ebola flare‑up in eastern…
    STAT · 3mo agoNegative↗ source
  • Former Surgeon General Calls for Clinician-Guided Framework to Regulate Popular Peptides
    Jerome Adams, the former U.S. surgeon general, argues that the FDA should adopt a middle‑ground strategy rather than banning peptide compounds outright. He notes the rapid growth of peptide use for…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Lancaster County emerges as new biotech hub as Boston faces layoffs
    Boston’s biotech sector is experiencing layoffs and vacant lab space, signaling a slowdown in the region that has long been a biotech stronghold. In contrast, Lancaster County, Pennsylvania, is wi…
    BioPharma Dive · 3mo agoNeutral↗ source
  • Ebola therapy development accelerates as multiple candidates enter early trials
    A new wave of research teams are racing to develop a therapy for Ebola, according to the latest Morning Rounds newsletter. The article notes that several candidates are now moving into early‑stage…
    STAT · 3mo agoNeutral↗ source
  • Physicians overuse diagnostic tests, urging structural changes to curb waste and antibiotic resistance
    American medicine orders more than 14 billion diagnostic tests each year, but many are performed at the wrong time or on patients who will not benefit. The author argues that while the industry ha…
    STAT · 3mo agoNegative↗ source
  • FDA grants first clearance for patient-facing LLM diabetes app, marking historic step for AI in medical software
    UpDoc's diabetes management app received FDA clearance, the first for software that uses patient-facing large language models. The app is designed to help patients follow treatment plans set by th…
    STAT · 3mo agoRegulatoryPositive↗ source
  • CDC leadership accused of stifling vaccine effectiveness studies and reshaping advisory committee role
    Ben Lopman, a professor of epidemiology and global health at Emory University, wrote an opinion piece warning that CDC leadership is trying to manufacture a scientific debate about vaccines where n…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Protillion Biosciences appoints Robert Hollingsworth as chief scientific officer
    Protillion Biosciences announced the hiring of Robert Hollingsworth as its new chief scientific officer. Hollingsworth joins Protillion after serving as chief scientific officer at Shoreline Therap…
    STAT · 3mo agoNeutral↗ source
  • Teen use of AI mental-health chatbots jumps 40% in a year, experts call for safety rules
    A recent study published in JAMA Pediatrics found that the proportion of adolescents turning to AI chatbots for mental-health advice rose from roughly one in eight to one in five within a single ye…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell Disease
    The U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…
    fda press · 3mo agoApprovalPositive↗ source
  • Ebola and Marburg outbreaks highlight need for pathogen-agnostic diagnostics
    The authors describe a current Bundibugyo Ebola outbreak affecting the Democratic Republic of Congo and Uganda, which has resulted in more than 1,300 confirmed cases and over 375 deaths. While the…
    STAT · 3mo agoNegative↗ source
  • FDA permits Zyn nicotine pouches to be marketed as safer than cigarettes
    The U.S. Food and Drug Administration announced that Zyn's nicotine pouches can be advertised as a safer alternative to traditional cigarettes. The decision reflects the agency's view that the pouc…
    STAT · 3mo agoRegulatoryPositive↗ source
  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 3mo agoApprovalPositive↗ source
  • Uganda reports Marburg cases, adding to regional Ebola crisis
    Uganda has informed the World Health Organization of a Marburg virus outbreak in its western region, confirming at least one case, with some sources indicating two cases. The emergence of Marburg,…
    STAT · 3mo agoNegative↗ source
  • FDA gene and cell therapy review office loses acting director Vijay Kumar
    Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source