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919 stories matching this filter · ← front page

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  • Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab
    Scribe writes in $96M IPO: The gene editing biotech expects net proceeds of about $96 million if it prices its Nasdaq listing at $14 per share, the midpoint of the ...
    Endpoints · 7d ago↗ source
  • Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics
    Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst caut…
    BioSpace · 7d ago↗ source
  • J&J, AbbVie said to have also looked at AtaiBeckley before Lilly’s $2.8B deal
    Johnson & Johnson and AbbVie, the two pharma giants already in the psychedelic space, also eyed AtaiBeckley, according to a source familiar with the situation, but didn’t make an offer before E…
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Endpoints · 7d ago
↗ source
  • FDA’s radical transparency policy for rejections runs into legal uncertainty
    Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
    BioSpace · 7d 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 · 7d ago↗ source
  • 2026 IPO class blooms again as BlossomHill, Latigo set sights on Nasdaq
    Eighteen companies have gone public this year so far, putting 2026 on pace to record the highest number of IPOs since the pandemic-driven high of 2021.
    BioSpace · 8d ago↗ source
  • Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals
    The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for…
    BioSpace · 8d ago↗ source
  • UK biotech VC funding rebounds and reaches record high
    UK biotechs attracted more venture capital funding in the second quarter of 2026 than in any full year since 2022, in a sign that the country is amid a fundraising revival as investors get attracti…
    Endpoints · 8d ago↗ source
  • Bristol Myers, Nvidia say they'll build 'most powerful' AI supercomputer in pharma
    Bristol Myers Squibb said Monday it will build "the most advanced and energy-efficient AI" supercomputer system in the biopharma industry, deepening its relationship with Nvidia. The New Jersey-h…
    Endpoints · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d ago↗ source