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264 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 · 19h 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 · 12h agoRegulatoryNeutral↗ source
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  • 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 · 15h agoNegative readoutNegative↗ 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 · 9h 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 · 12h 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 · 15h 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 · 15h 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 · 15h agoPositive readoutPositive↗ 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 · 16h agoPositive readoutPositive↗ 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 · 12h agoLayoffsNegative↗ source
  • Silence brings the noise to Takeda with phase 2 blood cancer win
    A phase 2 trial of Silence Therapeutics’ divesiran has hit its primary endpoint, emboldening the biotech to gear up for late-phase development of a potential challenger to Takeda and Protagonist Th…
    Fierce Biotech · 22h ago↗ 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 · 4d agoDealPositive↗ source
  • BioVie shares plunge as Parkinson’s trial results lack primary motor data
    BioVie reported results of its Phase 2 SUNRISE-PD study in early‑stage Parkinson’s disease. The double‑blind, placebo‑controlled trial enrolled 57 patients who had not yet received carbidopa/levodo…
    BioSpace · 4d agoNegative readoutNegative↗ 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 · 5d agoNegative readoutNegative↗ source
  • AstraZeneca and BMS deny merger talks, Reuters says no deal
    Reuters reported that rumors of a merger between AstraZeneca and Bristol Myers Squibb have been dismissed. A senior source close to the matter told Reuters there is no deal and no discussions betw…
    BioSpace · 5d agoDealNeutral↗ source
  • Novo Nordisk CEO says innovation is essential as pipeline faces setbacks
    During Novo Nordisk's second-quarter earnings call, CEO Maziar Mike Doustdar said that failure is a normal part of drug development and emphasized that the company's survival depends on continual i…
    BioSpace · 5d agoEarningsNeutral↗ source
  • Merger talks between Bristol Myers Squibb and AstraZeneca fade as Q2 earnings roll out and FDA advisory meetings heat up
    Talks of a possible merger between Bristol Myers Squibb and AstraZeneca have receded after analysts highlighted antitrust hurdles. Both companies, each valued over $130 billion, were rumored to con…
    BioSpace · 5d agoDealNeutral↗ 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
  • Five BioSpace NextGen companies debut on US markets in 2026, four actively hiring
    BioSpace NextGen honorees accounted for about one third of the 14 U.S. biotech companies that went public in 2026. The five companies together raised roughly $1.5 billion in IPO proceeds, includin…
    BioSpace · 5d agoPositive↗ source
  • Pfizer CEO says $7 billion cash ready for bolt‑on acquisitions and dividend will stay intact
    During its second‑quarter earnings call, analysts asked Pfizer if the company would increase M&A spending as rivals rush to buy biotech assets. CEO Albert Bourla replied that Pfizer currently has…
    BioSpace · 6d agoDealPositive↗ source
  • Pfizer adds $2.5 billion to restructuring, targeting $6 billion savings by 2029
    Pfizer announced an additional $2.5 billion in cost reductions as part of its ongoing restructuring program. The new cuts focus on technology and simplification across commercial, R&D and manufact…
    BioSpace · 6d agoNegative↗ source
  • As portfolio erodes, BMS stands to gain a lot from rumored AstraZeneca merger
    While both drugmakers face looming patent cliffs, analysts say joining forces could help Bristol Myers Squibb replenish its eroding portfolio—while the strategic case for AstraZeneca seems to be mo…
    BioSpace · 6d agoDealNeutral↗ source