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1,103 stories matching this filter · ← front page

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  • China drafts policy to block foreign buyouts of key cell-gene therapy and siRNA platforms
    China’s government has released a draft amendment to its export blacklist that would prohibit or tightly control foreign purchases of certain biopharmaceutical platforms. The rule targets propriet…
    Fierce Biotech · 4d agoRegulatoryNegative↗ source
  • Nouscom secures €120M to advance off-the-shelf cancer vaccine for Lynch syndrome
    Swiss biotech Nouscom announced a €120 million (about $135 million) Series D financing round. The capital will fund a registration-enabling pivotal trial of its cancer-preventing vaccine candidate.…
    Fierce Biotech · 4d agoDealPositive↗ source
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  • FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groups
    The FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practice requirements, citing problems with ensuring product sterility and meeting sp…
    raps · 4d agoRegulatoryNegative↗ source
  • Ambrose Healthcare acquires AM-Pharma for up to €161 million
    Ambrose Healthcare, a British rare‑disease specialist, announced it has completed the acquisition of Dutch biotech AM‑Pharma. The deal values the company at up to 161 million euros (about $181 mill…
    Fierce Biotech · 4d agoDealNeutral↗ source
  • City Therapeutics completes $200 million IPO, earmarks funds for RNAi therapies
    City Therapeutics, based in Cambridge, Massachusetts, launched an IPO raising $200 million, exceeding its original target of 9.7 million shares at $17-$19 per share. The company sold 11.1 million…
    Fierce Biotech · 4d agoDealPositive↗ source
  • FDA issues warning letters to drug makers and a lab over CGMP and GLP violations
    FDA sent warning letters to several drug manufacturers for not meeting current good manufacturing practice (CGMP) requirements. The letters point to issues such as ensuring final product sterility…
    raps · 4d agoRegulatoryNegative↗ source
  • Labcorp teams with Thrive Global to launch Thrive 5 home health test
    Labcorp has introduced the Thrive 5 Health Test in partnership with Arianna Huffington's company, Thrive Global. The test is sold through Labcorp's OnDemand home testing service and pairs laborato…
    Fierce Biotech · 4d agoPositive↗ source
  • Lidl US recalls Gelatelli Coffee & Vanilla Gelato over possible Listeria contamination
    Lidl US announced a recall of one lot of its Gelatelli Coffee & Vanilla Gelato with coffee sauce and cookie pieces, citing potential contamination with Listeria monocytogenes. The affected product…
    fda recalls · 4d agoCRLNegative↗ source
  • FDA issues early alert for Edwards Lifesciences’ mitral valve delivery system after reported death, injury
    The FDA has issued an early alert for certain delivery systems used with Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement system amid serious safety concerns.
    Fierce Biotech · 4d ago↗ source
  • Vanda pauses social anxiety program after ex-Novartis asset flunks phase 3 study
    A phase 3 trial of Vanda Pharmaceuticals’ social anxiety disorder drug candidate has missed its primary endpoint, prompting the company to put the program on hold.
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • Estuary Biotherapeutics raises $103M to advance gene therapies for polycystic kidney disease
    Estuary Biotherapeutics announced it has exited stealth mode after securing $103 million in financing to move two gene‑therapy candidates into clinical testing for autosomal dominant polycystic kid…
    Fierce Biotech · 5d agoDealPositive↗ source
  • AstraZeneca signs $1.5B AI partnership with insitro to discover liver and heart disease targets
    AstraZeneca announced a partnership with insitro, a biotech that uses artificial intelligence, with an upfront payment of $40 million and potential milestones up to $1.46 billion. The collaboratio…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Iambic Therapeutics raises $150 million in IPO to fund oncology drug development
    Iambic Therapeutics, a San Diego-based AI biotech, completed an initial public offering that raised $150 million, exactly meeting its goal of selling 9.4 million shares at $16 each. The company sa…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Experts call for dedicated regulatory framework for clinical AI models, UK MHRA unveils AI-focused strategy
    Former FDA commissioner Scott Gottlieb, now at the American Enterprise Institute, wrote an opinion piece urging Congress to create a specific regulatory framework for artificial intelligence models…
    raps · 5d agoRegulatoryPositive↗ source
  • EMA to cement ACT EU pilot; MHRA unveils AI-era regulatory strategy
    The European Medicines Agency announced that in January 2027 it will make permanent a pilot project that assists sponsors in preparing clinical trial applications, turning a temporary scheme into a…
    raps · 5d agoRegulatoryNeutral↗ source
  • IQVIA urges early clinical insight in drug discovery to boost patient benefit
    IQVIA Laboratories' leaders argue that drug discovery and clinical development should be linked early to improve patient outcomes. They explain that decisions made during discovery affect later cl…
    Fierce Biotech · 5d agoPositive↗ source
  • OrbiMed raises $3 billion, its biggest Asian fund yet, to boost biotech investments worldwide
    OrbiMed announced it has closed a $3 billion fundraising round, the largest ever for its Asia‑focused vehicle. The capital will be used to make new growth‑equity and venture investments in biotech…
    Fierce Biotech · 5d agoDealPositive↗ source
  • FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reports
    The FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter m…
    fda medwatch · 5d agoRegulatoryNegative↗ source
  • SimBioSys receives FDA clearance for Nvidia-powered AI tool to predict breast cancer recurrence
    SimBioSys announced FDA clearance for its TumorSight Risk platform, an AI-driven tool that uses MRI, pathology and clinical data to assess the likelihood of breast cancer returning. The cloud-base…
    Fierce Biotech · 5d agoRegulatoryPositive↗ source
  • FDA issues warning letters to manufacturers over CGMP and GLP violations
    The U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems e…
    raps · 5d agoRegulatoryNegative↗ source
  • Osivax’s flu vaccine OVX836 misses primary efficacy goal in phase 2b trial
    Osivax announced that its influenza A vaccine candidate OVX836 failed to meet the primary efficacy endpoint in a phase 2b trial involving 2,850 healthy adults in Europe. The trial showed a vaccine…
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • Experts call for Congress to create a dedicated regulatory framework for AI models used in academic medical centers
    On Oct. 15, 2026, several health policy experts voiced support for a new regulatory approach specifically aimed at clinical artificial‑intelligence models that are developed and deployed in academi…
    raps · 5d agoRegulatoryNeutral↗ source
  • Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O157:H7 Contamination
    WORCESTER, NY, October 15, 2026 - Family Farmstead Dairy of Worcester, NY is recalling specific lot of cheddar cheese because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli…
    fda recalls · 5d agoRegulatoryNeutral↗ source
  • Bausch + Lomb CEO Brent Saunders exits again, interim CEO Thomas Appio appointed
    Bausch + Lomb announced that CEO Brent Saunders is leaving the eye health company for a second time, less than four years into his latest tenure. The departure was mutually agreed upon by Saunders…
    Fierce Biotech · 5d agoNeutral↗ source
  • Lakefront Biotherapeutics sells its cell therapy pipeline to Belgian biotech Armed Cell Therapeutics
    Lakefront Biotherapeutics, formerly known as Galapagos Therapeutics, announced that it has sold its cell therapy pipeline to fellow Belgian biotech Armed Cell Therapeutics. The transferred assets…
    Fierce Biotech · 5d agoDealNeutral↗ source