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467 stories matching this filter · ← front page

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  • FDA cites companies for CGMP violations, informed consent failure
    <p>The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing t…
    raps · 6d ago↗ source
  • European Commission publishes guideline on transparency obligations under AI Act
    <p>The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act,…
    raps · 6d ago↗ source
  • Tempus to acquire cancer test maker Personalis for $1.5B
    <figure><div><img src="https://imgproxy.divecdn.com/_RbdDztrnLOoumxY2iZaJMnVrx0w3LSgoNSRO_aqxDg/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjE4Nzk4MTY3LmpwZ…
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BioPharma Dive · 6d ago
↗ source
  • Tempus to buy cancer test-maker Personalis for $1.5B
    <figure><div><img src="https://imgproxy.divecdn.com/_RbdDztrnLOoumxY2iZaJMnVrx0w3LSgoNSRO_aqxDg/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjE4Nzk4MTY3LmpwZ…
    BioPharma Dive · 6d ago↗ source
  • Pain drugmaker Latigo outlines plans to go public
    <figure><div><img src="https://imgproxy.divecdn.com/szYDL8kkQd6XaSVgvjJPYl2j0snveijWs_0sZ-B522Y/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDYyODUzODA3LmpwZ…
    BioPharma Dive · 6d ago↗ source
  • ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong
    Axiom Biosciences intends to pursue an IPO on the Hong Kong Stock Exchange (HKEX), followed by a co-listing on the Nasdaq—a strategy the company claims is the first U.S. biotech to use.
    Fierce Biotech · 6d ago↗ source
  • Bristol Myers to build ‘powerful’ AI factory; Samsung Biologics bids for peptide maker
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 6d ago↗ source
  • Genetic medicine luminaries launch new center for personalized therapies
    A team of veteran scientists from elite institutions has come together to form a new center dedicated to the crafting of personalized genetic medicines, adding to the growing list of similar effort…
    Fierce Biotech · 6d ago↗ source
  • [Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services
    <p>This podcast explores how clinical trial supplies move from early planning to global delivery, ensuring investigational medicines reach patients safely and on time.</p>
    BioPharma Dive · 6d ago↗ source
  • Kolon’s cell-based gene therapy fails phase 3 osteoarthritis trial
    A phase 3 trial of Kolon TissueGene’s cell-based gene therapy has missed its co-primary endpoints. With a second late-stage study scheduled to report data in October, the biotech is holding off on…
    Fierce Biotech · 7d ago↗ source
  • Tempus buys out cancer genomics partner Personalis in $1.5 billion deal
    Tempus is boosting its cancer offerings with a deal to buy out Personalis three years after the pair first teamed up in oncology.
    Fierce Biotech · 7d ago↗ source
  • Scribe aims for $96M IPO to fund clinical push for lipid-lowering genetic meds
    Scribe Therapeutics has put its IPO plans down on paper, showing the genetic medicine company hopes to raise $96 million through its public listing.
    Fierce Biotech · 7d ago↗ source
  • BMS expands AI footprint with Nvidia, aiming for ‘most powerful AI factory in life sciences’
    Bristol Myers Squibb has entered into an expanded collaboration with Nvidia to create the biggest supercomputer for drug R&D, according to the announcement.
    Fierce Biotech · 7d ago↗ source
  • Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5B
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 7d ago↗ source
  • Asia-Pacific Roundup: TGA seeks feedback on Australian regulations for digital mental health tools
    <p>Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to inform changes to the regulatory framework for digital mental health tools (DMHTs).</p>
    raps · 7d ago↗ source
  • Study: China outpaces the US in cancer approvals, lags behind on first approvals
    <p>While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more…
    raps · 7d ago↗ source
  • MHRA touts uptick in approvals in 2025-2026 annual report
    <p>The UK's Medicines and Healthcare products Regulatory Agency (MHRA) touted its achievements over the last year its 2025-2026 annual report to Parliament, which includes approving more new drugs…
    raps · 7d ago↗ source
  • Latigo preps IPO to fund non-opioid pain drug rival to Vertex’s Journax
    Latigo Biotherapeutics is preparing to go public in order to bankroll the development of its clinical-stage pipeline of non-opioid pain management drugs.
    Fierce Biotech · 7d ago↗ source
  • Geopolitics ‘chills’ British biotech IPO plans, despite $2B in Q2 VC funds
    Geopolitical uncertainty has continued to “chill” IPO sentiment among British biotechs, an industry leader has told Fierce, even as the sector saw second-quarter venture capital funding reach a fiv…
    Fierce Biotech · 8d ago↗ source
  • Abbott hit by cyberattack on cancer diagnostics, LabCentral portal businesses
    Abbott has been struck by several cyberattacks which targeted the medtech giant’s cancer diagnostics and LabCentral businesses. <br>
    Fierce Biotech · 8d ago↗ source
  • ‘A rising tide scenario’: Why other Big Pharmas could follow Lilly into psychedelics
    After Eli Lilly dived into the psychedelics space with a $2.8 billion upfront acquisition of AtaiBeckley last week, industry experts told Fierce that the deal would give the space added momentum.
    Fierce Biotech · 8d ago↗ source
  • Jasper gets a lifeline in merger with immune drugmaker Kira
    <figure><div><img src="https://imgproxy.divecdn.com/nnTWCzHBd9_O2uNBVPF6xmxcO0M-nRFDpca5z-2Xchs/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDMwNzQzODA0LmpwZ…
    BioPharma Dive · 9d ago↗ source
  • Arbutus, Sanofi escalate mRNA patent fights; InnoCare’s TYK2 contender advances
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 9d ago↗ source
  • Compounders maintain a firm grip on the GLP-1 market
    <figure><div><img src="https://imgproxy.divecdn.com/lCVH-hvKf5LWLXT4PQ6NchaxlwaNHmtv86eTe3TlyQU/g:nowe:0:107/c:2500:1412/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlc…
    BioPharma Dive · 9d ago↗ source
  • GSK shelves cough drug acquired in $2B deal
    <figure><div><img src="https://imgproxy.divecdn.com/mDk-h3NLB8udDPFuDlI7IPou1i9tJKJYucQXUnhK9vA/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMTc3MzEzMjc4LmpwZ…
    BioPharma Dive · 9d ago↗ source