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249 stories matching this filter · ← front page

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  • FDA issues early alert after BD needle set defects linked to four deaths
    The FDA’s Center for Devices and Radiological Health released an early alert warning clinicians to stop using Becton Dickinson’s intraosseous vascular access needle sets after reports of serious in…
    Fierce Biotech · 21h agoRegulatoryNegative↗ source
  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 15h agoRegulatoryNeutral↗ source
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Infectious Disease300
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 17h agoNegative readoutNegative↗ source
  • Silence Therapeutics’ Phase 2 Trial Shows Strong Efficacy of divesiran in Polycythemia Vera
    Silence Therapeutics reported that its siRNA candidate divesiran met the primary endpoint in a phase 2 study of patients with polycythemia vera. The trial enrolled 48 participants and 88% of those…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapy
    The U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent ap…
    STAT · 14h agoRegulatoryNegative↗ source
  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 18h agoNegative readoutNegative↗ source
  • Silence Therapeutics moves siRNA drug for polycythemia vera to Phase 3 after Phase 2 success
    Silence Therapeutics announced that its siRNA candidate divesiran achieved its primary endpoint in a Phase 2 study in patients with polycythemia vera, a rare blood cancer. The trial results showed…
    Endpoints · 18h agoPositive readoutPositive↗ source
  • Silence Therapeutics’ divesiran shows 88% response in Phase 2 polycythemia vera trial, challenging Takeda’s upcoming drug
    Silence Therapeutics reported results from a Phase 2 study of its RNA-based therapy divesiran in patients with polycythemia vera, a rare blood cancer that causes excessive red blood cell production…
    STAT · 18h agoPositive readoutPositive↗ source
  • Abiomed and Oscor advise correction of Impella catheter introducers due to leakage risk
    Abiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps. The issue involves 14Fr and 23Fr introducer kits,…
    fda medwatch · 1d agoCRLNeutral↗ source
  • Ensoma cuts staff again to focus on lead gene therapy for rare immune disease
    Boston‑based biotech Ensoma announced another round of layoffs as it narrows its efforts to its sole clinical candidate, EN‑374, aimed at treating X‑linked chronic granulomatous disease (X‑CGD). E…
    Fierce Biotech · 3d agoLayoffsNegative↗ source
  • AI’s role in medicine isn’t monolithic, says industry leader, urging nuanced adoption
    Priya Abani, CEO of health‑tech firm AliveCor, argues that asking whether AI is good for medicine is a question with an obvious answer: it is. She says the debate has become redundant and that the…
    STAT · 4d agoPositive↗ source
  • Braveheart Bio raises $382.5M in IPO to fund phase 3 trial of cardiac drug
    Braveheart Bio, a San Francisco biotech, completed an IPO that raised $382.5 million, exceeding its original target. The company increased the share count to 21.2 million and set the price at $18…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Novo Nordisk reports mixed trial results for CagriSema and ziltivekimab, cites setbacks and seeks bolt-on deals
    Novo Nordisk's chief executive said the company has experienced "a couple of setbacks" after recent trial data. The phase 3 study of ziltivekimab, an IL‑6 ligand antibody, did not show a statistica…
    Fierce Biotech · 6d agoNegative readoutNegative↗ source
  • Novo Nordisk CFO describes roller-coaster growth and stays optimistic about CagriSema after Q2 earnings
    Novo Nordisk CFO Karsten Munk Knudsen talked to Fierce after the company released its second-quarter earnings, reflecting on his nine-year tenure and the firm’s volatile performance. He recalled a…
    Fierce Biotech · 5d agoEarningsNeutral↗ source
  • Only one third of US prostate cancer patients received pre-biopsy MRI in 2022, far below Western norms
    MRI is considered the standard pre-biopsy imaging tool for prostate cancer in most western nations, yet a new analysis shows that only about a third of US cases used it in 2022. In the United Stat…
    STAT · 5d agoNegative↗ source
  • Medical Action Industries issues correction for convenience kits with recalled Namic manifolds
    Medical Action Industries has issued a correction notice for certain convenience kits that contain Namic manifolds previously recalled by Medline. The company advises customers to immediately chec…
    fda medwatch · 8d agoCRLNegative↗ source
  • Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus risk
    The FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices. The recall follows a higher‑than‑expected rate of complaints i…
    fda medwatch · 11d agoCRLNegative↗ source
  • Karyopharm stock tumbles after Phase 3 Xpovio trial fails in endometrial cancer
    Karyopharm announced that its Phase 3 XPORT-EC-042 study of Xpovio in endometrial cancer did not meet its primary endpoint. The failure represents the company's second unsuccessful attempt to expa…
    Endpoints · 10d agoNegative readoutNegative↗ source
  • Syphilis cases rise among unhoused drug users at San Diego-Tijuana border as researchers face NIH limits and penicillin shortage
    Researchers at the University of California San Diego have been working for years to build trust with unhoused people who use drugs on both sides of the San Diego‑Tijuana border. Their outreach has…
    STAT · 10d agoNegative↗ source
  • Bristol Myers pushes Cobenfy Alzheimer’s psychosis readout to early 2027 after enrollment delays
    Bristol Myers Squibb said the Phase 3 readout for its Cobenfy Alzheimer’s psychosis program will be postponed to early 2027. The company had previously expected data from the three Adept trials to…
    Fierce Biotech · 11d agoNegative readoutNegative↗ source
  • Ebola cases approach key milestone as vaccine candidates draw near completion
    The latest update on the Ebola outbreak indicates that the number of cases is approaching a significant threshold, while vaccine development efforts are reported to be close to delivering a usable…
    STAT · 11d agoNeutral↗ source
  • Red Bull-funded studies downplay risks of mixing energy drinks with alcohol, shaping policy despite independent warnings
    An investigative report found that research funded by the energy‑drink maker contradicted the bulk of independent studies on the dangers of combining alcohol with caffeinated beverages. The funded…
    STAT · 12d agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 12d agoRegulatoryNegative↗ source
  • Nanoparticle-loaded chemotherapy crosses blood-brain barrier in mice after glioblastoma surgery, study shows
    Researchers at the University of Manchester have demonstrated that a standard chemotherapy drug can reach the brain when packaged in liposome nanoparticles and given shortly after tumor removal in…
    Fierce Biotech · 12d agoPositive↗ source
  • Biogen CEO says company will pause new acquisitions and focus on developing existing pipeline
    Biogen's chief executive Christopher Viehbacher told analysts during the second-quarter earnings call that the company will slow its merger and acquisition activity for the foreseeable future. Aft…
    Fierce Biotech · 12d agoDealNeutral↗ source