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658 stories matching this filter · ← front page

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  • FDA says former officials' journal articles do not represent agency policy after lawmaker criticism
    Acting FDA director Kyle Diamantas wrote to House Energy & Commerce ranking member Diana DeGette, stating that journal papers authored by former agency officials do not convey FDA policy or regulat…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Jasper Therapeutics merges with Kira Pharmaceuticals, divests Tavneos rival to Mirador
    Jasper Therapeutics announced a merger with Nasdaq‑listed Kira Pharmaceuticals, positioning the combined company for a fresh strategic direction. The deal follows a difficult period for Jasper, whi…
    Fierce Biotech · 1mo agoDealPositive↗ source
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  • Sonothera touts ultrasound gene-delivery platform for Duchenne, but experts remain skeptical
    Sonothera, a California startup, says its ultrasound‑based technology can deliver therapeutic genes into cells, a method it believes could treat Duchenne muscular dystrophy and other genetic disord…
    STAT · 1mo agoNeutral↗ source
  • Amylyx to read out pivotal endocrine drug study results later this quarter
    Amylyx Pharmaceuticals will read out results later this quarter from a study of a new treatment for a rare endocrine disorder. The drug, avexitide, is being developed to prevent severe, uncontroll…
    STAT · 1mo agoNeutral↗ source
  • CMS proposes new payment framework for clinical software and AI to link reimbursement with patient outcomes
    The Centers for Medicare & Medicaid Services (CMS) has released proposed rules for 2027 that would create a standardized payment structure for clinical software and artificial intelligence tools. T…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Cue Biopharma appoints Dominic Borie as chief medical officer and head of R&D
    Cue Biopharma announced the hiring of Dr. Dominic Borie, MD, PhD, as its new chief medical officer and head of research and development. Borie joins from Kyverna Therapeutics, where he served as a…
    Fierce Biotech · 1mo agoPositive↗ source
  • Defense Secretary proposes annual testosterone screening for service members, sparking mixed expert reaction
    U.S. Defense Secretary Pete Hegseth announced that service members will have testosterone deficiency testing added to their annual physical exams. The plan targets war-fighters aged 30 and older, w…
    STAT · 1mo agoNeutral↗ source
  • Celcuity’s breast cancer therapy gets FDA approval as new CBER chief outlines biotech priorities
    Celcuity announced that its first breast cancer drug has been approved by the U.S. Food and Drug Administration, marking the company’s initial market entry in oncology. The announcement coincided…
    STAT · 1mo agoApprovalPositive↗ source
  • Senator Lindsey Graham’s death highlights gaps in detecting aortic dissection
    Senator Lindsey Graham, 71, died on Saturday after suffering an aortic dissection, a sudden tear in the body's main blood vessel that can be fatal. A final death certificate has not yet been relea…
    STAT · 1mo agoNegative↗ source
  • Ebola outbreak in Congo tops 2,000 cases as health workers strike over unpaid wages
    The Congo Ministry of Health reported on July 15 that confirmed Ebola cases have risen to 2,011, with 754 deaths, making it the fastest-growing outbreak on record. Health workers at Bunia General…
    STAT · 1mo agoNegative↗ source
  • Study reveals how Epstein-Barr virus triggers immune response in multiple sclerosis
    A study published in Science Translational Medicine describes how infection with Epstein-Barr virus (EBV) initiates the immune reactions that lead to inflammation and nerve damage in people with mu…
    STAT · 1mo agoPositive↗ source
  • Axiom's stem cell therapy shows zero mortality in phase-1 trial for newborn brain injuries
    Axiom Biosciences reported that its mesenchymal stem cell (MSC) therapy achieved a 0% mortality rate over two years in a phase‑1 study of newborns with severe brain injuries. The nine‑patient trial…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Mwyngil Therapeutics launches obesity program that avoids GLP-1 pathway
    Mwyngil Therapeutics, a newly formed biotech startup, is pursuing obesity treatments that do not target the GLP-1 receptor, a pathway that has dominated recent weight-loss drug development. CEO Lu…
    STAT · 1mo agoNeutral↗ source
  • Senator Lindsey Graham's death from aortic dissection spotlights need for better screening
    Senator Lindsey Graham died at age 71 after suffering an aortic dissection, drawing public attention to this rare but deadly condition. An aortic dissection occurs when the body's main blood vesse…
    STAT · 1mo agoNegative↗ source
  • Ebola outbreak in eastern Congo accelerates, 80% of new cases from unknown transmission chains
    WHO emergencies chief Chikwe Ihekweazu said the Ebola outbreak in eastern Congo is outpacing response efforts, noting that many recent deaths occurred in communities without reaching health facilit…
    STAT · 1mo agoNegative↗ source
  • Ohio launches $30M Life Science Training Center to boost biomanufacturing workforce
    Ohio’s JobsOhio agency and the Ohio Life Sciences Association announced a public-private training center backed by up to $30 million. The center is intended to create a statewide pipeline of operat…
    Fierce Biotech · 1mo agoPositive↗ source
  • Airlines rely on volunteer doctors to handle common in‑flight medical complaints
    Physicians frequently volunteer to assist on commercial flights after a cabin announcement asks, “Is there a doctor on board?” The author, a hematologist‑oncologist, notes that he responded on thre…
    STAT · 1mo agoNeutral↗ source
  • Roche stops two Huntington's disease gene-silencing programs after disappointing trial data
    Roche announced it is ending development of two gene‑silencing candidates aimed at Huntington's disease after data failed to meet expectations. The decision follows a recent readout that showed in…
    STAT · 1mo agoNegative↗ source
  • ARPA-H awards $160 M to accelerate bespoke gene‑editing therapies for rare diseases
    ARPA-H announced a $160 million, five‑year investment through its THRIVE program to speed the development of personalized gene‑editing treatments for rare genetic conditions. The awardees include…
    BioPharma Dive · 1mo agoNeutral↗ source
  • German Parliament votes to double mandatory drug rebate to 15.5%, sparking industry concerns
    German lawmakers have approved a bill that would raise the mandatory rebate that drug manufacturers must give the government on branded medicines from the current 7% to 15.5%. The increase is inte…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA delays deadline for electric shock device ban
    The Food and Drug Administration has quietly moved the enforcement date for the ban on certain electric shock devices to a later point in time. The agency did not issue a high‑profile announcement,…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • 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 · 2mo agoPositive↗ source
  • ARPA-H earmarks $160 million for custom gene-editing therapies, sparking debate on adequacy
    ARPA-H announced a $160 million investment to support development of bespoke gene‑editing treatments. This follows a recent case where an infant was rescued from a lethal disease using a personaliz…
    Endpoints · 2mo agoNeutral↗ 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 · 2mo agoNegative readoutNegative↗ source
  • 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 · 2mo agoNegative↗ source