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874 stories matching this filter · ← front page

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  • 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 · 4d 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 · 5d 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.
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Fierce Biotech · 5d ago
↗ source
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 5d ago↗ source
  • How Kyverna rode CAR T’s autoimmune wave to the FDA’s door
    Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
    BioSpace · 5d 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 · 5d 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 · 5d 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 · 5d 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 · 5d 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 · 5d 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 · 6d 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 · 6d ago↗ source
  • Biogen’s mixed Alzheimer’s data; Two new startups launch; and more
    Welcome back to another edition of Endpoints Weekly! We hope you all have been staying safe indoors as the Canadian wildfires blanketed much of the US Northeast this week. Hopefully things calm dow…
    Endpoints · 6d 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 · 6d ago↗ source
  • Midsized biotechs press White House to drop CMS pricing rules
    A number of midsized biotech companies have met with White House and HHS officials in the last week, presenting their case for why two pending CMS pricing models could hinder their business and sho…
    Endpoints · 7d ago↗ source
  • Celcuity got its cancer drug approved. Then its stock dipped
    The FDA’s approval for Celcuity’s cancer drug Revtorpyk on Tuesday was widely anticipated. What Wall Street didn’t expect was that the drug could take until the end of the quarter to launch. ...
    Endpoints · 7d ago↗ source
  • India’s life sciences sector at turning point for innovation: Report
    Structural gaps in areas including clinical execution and funding limit India’s ability to scale up innovation, according to a report from Boston Consulting Group and HealthKois.
    BioSpace · 7d ago↗ source
  • GSK plans large study to see if shingles vaccine can prevent dementia
    LONDON — Over the past several years, data scientists searching through national health records have noticed something surprising about people who had been vaccinated for shingles: They were less l…
    Endpoints · 7d ago↗ source
  • Dimerix buys a kidney injury drug; Arpeggio appears to be winding down
    Plus, news about Takeda, Novartis and Regenxbio. 🤝 Mission sells kidney injury drug to Dimerix: Dimerix will pay $5 million upfront for Mission’s Phase 2-ready candidate for acute kidney injury,…
    Endpoints · 7d ago↗ source
  • Updated: BlossomHill and Latigo join flourishing IPO queue with cancer, pain drugs
    Last summer, zero biotechs made it onto the public markets as the industry weathered a seven-month dry spell for initial share sales. This time around, it's a summer IPO party as six
    Endpoints · 7d ago↗ source
  • GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 fail
    Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.
    BioSpace · 7d ago↗ source
  • BlossomHill eyes IPO as fertilizer to grow taller in crowded cancer fields
    Another biotech is squeezing into the crowded IPO waiting room just in time for the weekend. BlossomHill Therapeutics, a San Diego-based oncology outfit focused on small molecules, has filed paperw…
    Fierce Biotech · 7d ago↗ source
  • Insmed moves closer to $6B opportunity as PAH drug shows long-term durability
    Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements thro…
    BioSpace · 7d ago↗ source
  • FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking
    Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Ener…
    BioSpace · 7d ago↗ source
  • GSK drops Phase 3 chronic cough drug in a blow to $2B Bellus Health buyout
    In a major stumble for GSK’s $2 billion acquisition of Bellus Health, the UK pharma said Friday it is ending development of camlipixant in refractory chronic cough (RCC) after the drug ...
    Endpoints · 7d ago↗ source