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1,583 stories matching this filter · ← front page

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  • Kyverna Therapeutics aims to file first CAR-T cell therapy for autoimmune disease
    Kyverna Therapeutics is preparing what could become the first regulatory filing for a CAR-T cell therapy targeting an autoimmune condition. The company has been developing its miv-cel construct in…
    BioSpace · 27d agoRegulatoryPositive↗ source
  • Kolon’s cell-based gene therapy misses key endpoints in phase 3 osteoarthritis trial
    Kolon TissueGene reported that its phase 3 study of TG‑C, a cell‑based gene therapy for knee osteoarthritis, failed to meet its co‑primary endpoints. Patients receiving the therapy showed no statis…
    Fierce Biotech · 27d agoNegative readoutNegative↗ source
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  • HHS vaccine committee receives new charter amid broader health policy updates
    The U.S. Health and Human Services vaccine advisory panel has been granted a new charter, a change that was noted quietly in a recent health newsletter. The same briefing highlighted other policy…
    STAT · 26d agoRegulatoryNeutral↗ source
  • Pandemics Should Be Treated as National Security Threats, Experts Argue
    In an opinion piece, David Blumenthal and James A. Morone argue that pandemics should be classified and addressed as national security threats rather than solely health-care challenges. They note…
    STAT · 27d agoPositive↗ source
  • FDA maintains focus on Taylor Farms lettuce as source of cyclospora outbreak despite false‑positive test
    Federal health officials said on Monday that the FDA continues to target shredded lettuce from Taylor Farms as the likely source of a multistate cyclospora outbreak, even after a laboratory result…
    STAT · 26d agoRegulatoryNeutral↗ source
  • Physician blames U.S. health insurance failures after husband's suicide
    Joy Evers, an emergency physician, recounts the death of her husband Randy by suicide, describing how she expected her family’s high-quality commercial health insurance to ensure he received timely…
    STAT · 27d agoNegative↗ source
  • Fugitive ex-doctor arrested after two decades posing as biotech executive
    Federal and Rhode Island authorities arrested Ronald Fischer, 70, after tracking a 56-foot sailboat off New Jersey. He had been on the run for about 20 years. Fischer, a former anesthesiologist, v…
    STAT · 26d agoRegulatoryNegative↗ source
  • Latigo Biotherapeutics plans IPO to fund phase 3 trials of non-opioid pain drug LTG-001
    Latigo Biotherapeutics announced it is preparing an initial public offering to raise capital for its clinical-stage, non-opioid pain management pipeline. The company highlighted its oral Nav1.8 in…
    Fierce Biotech · 27d agoDealNeutral↗ source
  • Geopolitical uncertainty dampens UK biotech IPO outlook despite record Q2 venture funding
    Geopolitical uncertainty continues to weigh on the sentiment around initial public offerings for British biotech companies, according to an industry leader speaking to Fierce. At the same time, th…
    Fierce Biotech · 28d agoNeutral↗ source
  • Abbott reports cyberattack on cancer diagnostics and LabCentral portal, says operations unaffected
    Abbott announced that a cyber incident on July 16 accessed a limited number of internal systems in its cancer diagnostics unit. The company said the breach does not affect product availability, ma…
    Fierce Biotech · 28d agoNegative↗ source
  • Eli Lilly’s $2.8 bn purchase of AtaiBeckley adds psychedelic candidate BPL‑003, sparking optimism for broader mental‑health drug pipeline
    Eli Lilly announced it has acquired AtaiBeckley for $2.8 billion, bringing the privately held biotech’s lead psychedelic program into its portfolio. The deal gives Lilly access to BPL‑003, an intr…
    Fierce Biotech · 29d agoDealPositive↗ source
  • U.S. Military's New Testosterone Screening Raises Health Concerns
    The Department of Defense announced a mandatory testosterone screening program for all service members, prompting discussion among medical experts. A urologist who studies men’s health cautions th…
    STAT · 28d agoNegative↗ source
  • STAT invites reader letters on primary care value, obesity as disease and broader health-care debates
    STAT’s First Opinion platform encourages readers to submit letters responding to its essays, fostering open, good‑faith discussion about health‑care topics. Recent letters, echoing comments from t…
    STAT · 29d agoNeutral↗ source
  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 29d agoApprovalPositive↗ source
  • Abbott Beats Q2 Expectations with Strong Device and Diagnostic Sales, Raises Profit Forecast
    Abbott reported second‑quarter results that exceeded analysts' forecasts, easing concerns about potential impact of ACA subsidy cuts on medtech firms. Diagnostics revenue jumped 42% year‑over‑year…
    Fierce Biotech · 1mo agoEarningsPositive↗ source
  • Sonothera reports ultrasound method delivers high levels of dystrophin in monkeys, a potential new route for Duchenne therapy
    A California startup, Sonothera, is proposing an ultrasound‑based approach to deliver genes for Duchenne muscular dystrophy treatment. The company says its technology can introduce full-size dystr…
    STAT · 1mo agoPositive readoutNeutral↗ source
  • Dimerix acquires Mission's phase-2 ready AKI drug in $292 million deal
    Dimerix announced it has acquired the acute kidney injury candidate MTX652 from Mission Therapeutics in a deal valued at up to $292 million, including a $5 million upfront payment. Mission had com…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Medicare proposal would boost doctor pay for smoking and alcohol counseling by 19%
    A proposed change to Medicare’s physician fee schedule would increase reimbursement for doctors who provide counseling on tobacco cessation and alcohol or substance misuse. The proposal adds a 19%…
    STAT · 29d agoRegulatoryPositive↗ source
  • India’s life-sciences sector faces scaling hurdles despite rapid innovation growth, report says
    India’s life‑sciences sector has shown rapid growth, according to a new report by Boston Consulting Group and HealthKois. Patent filings have risen more than four‑fold since 2016, the pipeline of i…
    BioSpace · 29d agoNeutral↗ source
  • U.S. drug shortages climb to 227 active cases in Q2 2026
    The United States reported a rise in active medication shortages during the second quarter of 2026, with the total reaching 227. The increase signals growing pressure on the pharmaceutical supply…
    STAT · 29d agoNeutral↗ source
  • GSK drops chronic cough drug camlipixant after mixed Phase 3 results
    GSK announced it will stop investing in camlipixant for refractory chronic cough after the drug failed to meet key endpoints in a late-stage trial. The company had run two Phase 3 studies, CALM-1…
    BioSpace · 29d agoNegative readoutNegative↗ source
  • San Diego biotech BlossomHill files for IPO to fund EGFR lung-cancer drug program
    BlossomHill Therapeutics, a San Diego oncology biotech focused on small‑molecule drugs, has filed an S‑1 registration statement to become a public company. The company, founded in February 2024 by…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Insmed's inhaled PAH therapy shows durable efficacy in 12-month extension, bolstering $6B sales outlook
    Insmed reported that its inhalable prostanoid candidate, treprostinil palmitil inhalation powder (TPIP), maintained functional and biomarker benefits through a 12‑month open‑label extension in pati…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • 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