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1,288 stories matching this filter · ← front page

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  • Tenax Therapeutics' heart failure drug TNX-103 misses primary endpoint in Phase 3, shares plunge 85%
    Tenax Therapeutics announced that its investigational heart failure drug TNX-103 failed to meet the primary efficacy endpoint in the Phase 3 LEVEL trial. The trial, which enrolled patients with pu…
    BioSpace · 6h agoNegative readoutNegative↗ source
  • Eli Lilly's $3.8 B acquisition of AtaiBeckley signals growing confidence in psychedelics for depression
    Psychedelics are being touted as a potential solution for patients who still struggle to find lasting relief from existing FDA‑approved psychiatric medicines. The article notes that many individual…
    BioSpace · 14h agoDealPositive↗ source
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fda recalls35
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Endocrinology & Metabolism318
Ophthalmology313
Pain306
Infectious Disease299
  • 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 · 6h agoNegative readoutNegative↗ source
  • Biogen’s ALS drug shows symptom improvement in some patients three years after approval
    Biogen’s antisense therapy tofersen, marketed as Qalsody, received FDA approval three years ago as the first treatment to target a genetic form of ALS linked to the SOD1 gene. Since then, a number…
    BioSpace · 14h agoPositive readoutPositive↗ source
  • BMS commits $2.3 billion to build modular manufacturing campus in Houston, creating 2,500 jobs
    Bristol Myers Squibb announced a $2.3 billion investment to construct a new manufacturing campus in Houston, Texas. The site will cover about 600,000 square feet and is designed to be modular, allo…
    BioSpace · 1h agoPositive↗ 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 · 3h agoRegulatoryNegative↗ source
  • Psychedelic firms Definium and Compass poised for key data releases
    Investors and analysts are focusing on two psychedelic companies as they approach pivotal milestones. Definium Therapeutics is set to release Phase 3 Voyage data for its single-dose oral LSD candi…
    BioSpace · 4h agoPositive readoutPositive↗ source
  • AstraZeneca and CSPC launch joint venture to build biologics plant in Shijiazhuang
    AstraZeneca and China's CSPC Pharmaceutical have formed a joint venture to construct a biologics manufacturing facility in Shijiazhuang. The agreement follows AstraZeneca's pledge earlier this year…
    BioSpace · 4h agoDealPositive↗ 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 · 7h agoNegative readoutNegative↗ 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 · 7h agoPositive readoutPositive↗ source
  • BioMarin drops BMN 401 after Phase 3 trial misses clinical endpoints, ending $270M Inozyme asset
    BioMarin announced it will stop development of BMN 401, an enzyme replacement therapy acquired in its $270 million purchase of Inozyme Pharma. The decision follows the Phase 3 ENERGY trial in pati…
    BioSpace · 7h agoNegative readoutNegative↗ source
  • Safety concerns emerge as radiopharmaceuticals advance in cancer trials
    Radiopharmaceuticals are being hailed for their ability to deliver radiation directly to tumours, potentially sparing surrounding healthy tissue and improving cancer therapy. However, as more cand…
    STAT · 10h agoNegative↗ source
  • Global Ebola preparedness fixated on one strain, leaving gaps for other species
    Krutika Kuppalli, a former WHO medical officer, and virologist Placide Mbala write that the world’s readiness for Ebola has been narrowly focused. They draw on Kuppalli’s experience in the 2014‑201…
    STAT · 10h agoNegative↗ source
  • China clamps down on investigator-initiated clinical trials, tightening oversight
    China has announced tighter oversight of investigator-initiated trials (ITTs), requiring these studies to obtain approval from the National Medical Products Administration before they can begin. Th…
    STAT · 10h agoRegulatoryNeutral↗ source
  • AGC Biologics targets in-vivo gene therapies with stable producer lines and next-gen purification
    The industry is moving from ex vivo to in vivo gene delivery, a change that forces viral vector manufacturers to rethink scale, purity, cell lines and analytical methods. In in vivo approaches the…
    BioSpace · 11h agoPositive↗ source
  • BMS's Cobenfy faces market hurdles as side effects limit uptake, MapLight eyes opportunity
    The FDA approved Bristol Myers Squibb's Cobenfy in 2024, marking the first novel schizophrenia treatment in 35 years and raising hopes for a new therapeutic approach. Since its launch, the drug ha…
    BioSpace · 14h agoNegative↗ source
  • FDA to require companies to notify agency of new food additives, creating public database
    The Health and Human Services Department announced a new policy that obligates manufacturers to inform the FDA when they introduce a new substance into human or animal food, and to explain how they…
    STAT · 3h agoRegulatoryNeutral↗ source
  • Latigo and BlossomHill file Nasdaq IPO plans to fund pain and cancer pipelines
    Latigo Biotherapeutics and BlossomHill Therapeutics, both based in California, have filed applications to list on the Nasdaq Global Select Market. Latigo aims to raise up to $285.2 million to advan…
    BioSpace · 7h agoDealNeutral↗ source
  • Denali Therapeutics' Avlayah generates $3.6M in Q1, beating forecasts
    Denali Therapeutics reported that its newly launched Hunter syndrome therapy Avlayah earned $3.6 million in revenue during the first quarter after its April market entry. Analysts had projected ro…
    BioSpace · 8h agoPositive readoutPositive↗ source
  • States urged to use low-cost, scalable outreach for Medicaid enrollees facing 2027 eligibility changes
    States must begin notifying Medicaid beneficiaries about upcoming eligibility changes by September, as required by the One Big Beautiful Bill Act of 2025. The changes, set to take effect in 2027, i…
    STAT · 10h agoNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 4h agoLayoffsNegative↗ source
  • STAT+: Ban prior auth? And hospitals cut jobs
    We examine a call to reform how health insurers do business, and a look at the impact of 340B restrictions.
    STAT · 4h ago↗ source
  • Sionna’s cystic fibrosis failure is a windfall for Vertex’s blockbuster franchise
    A surprise flop in Phase 2a cystic fibrosis trial sent Sionna’s shares plummeting, but for Vertex, the news reinforced its standard-of-care standing with highly successful drugs like Trikafta.
    BioSpace · 4h ago↗ source
  • STAT+: FDA panel to weigh Grail’s Galleri test
    China reins in its biotech innovation engine, radiopharma boom meets unexpected hurdles, and more news from The Readout
    STAT · 4h ago↗ source
  • Jazz commits up to $1.3B to buy Actio, bolster epilepsy pipeline
    Jazz Pharmaceuticals is reaching into its wallet once again, this time buying Actio Biosciences and an experimental therapy for KCNT1+ epilepsy, a form of the disease with no FDA-approved treatments.
    BioSpace · 4h ago↗ source