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  • FDA advisory panel to consider reclassifying several widely used peptides
    An FDA advisory committee is meeting this week to decide whether it will recommend reclassifying a group of popular peptide products. The discussion comes as the industry watches closely for any sh…
    Endpoints · 24d agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, impacting healthcare AI developers
    The European Commission published new guidelines on Monday to help providers and deployers of AI systems meet the transparency obligations set out in the EU AI Act. The guidance includes examples…
    raps · 24d agoRegulatoryNeutral↗ source
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  • EU releases AI Act transparency guidelines, affecting health-tech developers
    The European Commission has published new guidelines to help providers and users of artificial intelligence systems meet the transparency obligations set out in the EU AI Act. The document explain…
    raps · 24d agoRegulatoryNeutral↗ source
  • Tempus AI to buy cancer test maker Personalis for $1.5 billion
    Tempus AI announced it will acquire Personalis, a California-based company that offers a molecular residual disease test for cancer, in a transaction valued at $1.5 billion. The deal, priced at $1…
    BioPharma Dive · 25d agoDealPositive↗ source
  • Samsung Biologics to acquire Swiss CDMO PolyPeptide for $1.8 billion, entering peptide API market
    Samsung Biologics announced a plan to purchase Swiss contract development and manufacturing organization PolyPeptide for $1.8 billion in cash. The acquisition will extend Samsung Biologics' manufa…
    Endpoints · 25d agoDealPositive↗ source
  • UK regulator reports rise in drug approvals and new AI healthcare regulations
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines in the past year…
    raps · 25d agoRegulatoryPositive↗ source
  • Study finds China approved more cancer drugs than US between 2020-2025, but US led in first-in-class and speed
    A new analysis published in Health Affairs compares oncology drug approvals by China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) from 2020 thro…
    raps · 25d agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps to regulate AI in healthcare
    The Medicines and Healthcare products Regulatory Agency (MHRA) presented its 2025-2026 annual report to Parliament, highlighting a higher number of new drug approvals compared with the previous yea…
    raps · 25d agoRegulatoryPositive↗ source
  • Tempus AI to acquire cancer test maker Personalis for $1.5 billion
    Tempus AI announced it will buy Personalis, a Fremont-based company that offers a molecular residual disease test for cancer, in a deal valued at $1.5 billion. The acquisition is expected to expan…
    BioPharma Dive · 25d agoDealPositive↗ source
  • Latigo Biotherapeutics Announces Plans for Nasdaq IPO to Fund Non-Opioid Pain Drug Development
    Latigo Biotherapeutics, a Westlake BioPartners spin‑out founded in 2018, said it will seek a Nasdaq listing under the ticker LTGO. The company develops non‑opioid analgesics that block sodium ion…
    BioPharma Dive · 25d agoDealPositive↗ source
  • Anthropic ramps up biopharma push with Nobel hires and M&A plans
    Anthropic, known for its artificial‑intelligence models, is expanding its focus to life sciences after a detailed internal memo outlined the move. The memo, released in late 2024, named biology an…
    Endpoints · 25d agoPositive↗ source
  • UK biotech venture capital funding hits record high in Q2 2026, surpassing any full year since 2022
    UK biotech companies secured more venture capital in the second quarter of 2026 than they did in any full calendar year since 2022. The surge reflects a broader fundraising revival, with investors…
    Endpoints · 25d agoDealPositive↗ source
  • Bristol Myers Squibb partners with Nvidia to build pharma's most advanced AI supercomputer
    Bristol Myers Squibb announced it will construct what it calls the most advanced and energy-efficient AI supercomputer system in the biopharma sector. The project will be carried out in partnershi…
    Endpoints · 25d agoDealPositive↗ source
  • UnitedHealth outlines AI rollout as quarterly results beat expectations
    UnitedHealth Group, a major health insurer, announced a substantial investment in artificial intelligence earlier this year. The company recently detailed how the technology is being integrated in…
    Endpoints · 25d agoPositive↗ source
  • House lawmakers support US trade panel's probe into China's biotech sector and pricing practices
    At least ten members of the U.S. House of Representatives have voiced support for a trade investigation targeting China’s biotechnology industry. The investigation, led by a U.S. trade panel, will…
    Endpoints · 25d agoRegulatoryNeutral↗ source
  • J&J and AbbVie also considered AtaiBeckley before Lilly’s $2.8 B acquisition
    Johnson & Johnson and AbbVie were reported to have evaluated AtaiBeckley as a potential target in the psychedelic market. The companies did not submit an offer before Eli Lilly closed its $2.8 bil…
    Endpoints · 25d agoDealNeutral↗ source
  • Bristol Myers teams with Nvidia to launch large AI data center as Samsung Biologics bids $1.8 bn for Swiss peptide maker
    Bristol Myers Squibb announced expansion of its partnership with Nvidia, deploying two AI systems to create a powerful AI factory for life‑science research, aiming to tackle larger problems without…
    BioPharma Dive · 25d agoDealNeutral↗ source
  • Scribe targets $96 million from Nasdaq IPO as Scholar Rock awaits site classification for apitegromab
    Scribe, a gene-editing biotech, announced plans for a Nasdaq initial public offering that could raise roughly $96 million. The company said it would price the shares at $14 each, which is the midp…
    Endpoints · 25d agoDealNeutral↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 25d agoRegulatoryNeutral↗ source
  • Biogen reports mixed Alzheimer’s trial results as industry sees new startup launches
    Biogen released data from its Alzheimer’s program that showed mixed outcomes, indicating some signals but also setbacks. The weekly newsletter also highlighted the launch of two new biotech startu…
    Endpoints · 27d agoNeutral↗ source
  • Compounders still supply about 20% of US GLP-1 weight-loss market despite FDA crackdown and shortages
    A recent Gallup survey shows that while the number of Americans taking GLP-1 weight‑loss drugs has nearly quadrupled over the past two years, roughly one in five are using cheaper, non‑FDA‑approved…
    BioPharma Dive · 28d agoRegulatoryNegative↗ source
  • BlossomHill and Latigo lead a surge of biotech IPOs after summer dry spell
    After a seven‑month lull that left no biotech companies on the public markets last summer, the sector is seeing renewed activity. BlossomHill Therapeutics and Latigo have filed to list on Nasdaq,…
    Endpoints · 28d agoDealPositive↗ source
  • GSK drops camlipant cough drug after mixed Phase 3 results
    GSK announced it is halting development of camlipant, an experimental chronic cough medicine it acquired in a $2 billion purchase three years ago. The decision follows two Phase 3 trials that show…
    BioPharma Dive · 28d agoNegative readoutNegative↗ source
  • Mid-size biotech firms urge White House to scrap CMS GLOBE and GUARD pricing proposals
    A group of midsized biotechnology companies met with officials from the White House and the Department of Health and Human Services this week. The companies presented a coordinated case to senior p…
    Endpoints · 28d agoRegulatoryNegative↗ source
  • Celcuity's Revtorpyk receives FDA approval, but launch delay pushes stock lower
    The FDA announced approval of Celcuity’s oncology candidate Revtorpyk on Tuesday, marking the company’s first cancer drug clearance. Analysts had broadly expected the approval and had priced the s…
    Endpoints · 28d agoApprovalNeutral↗ source