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2,384 stories matching this filter · ← front page

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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 · 27d agoRegulatoryNeutral↗ source
  • Right-wing groups intensify campaign to limit abortion pills amid ongoing health news
    Advocates on the political right are renewing efforts to restrict access to medication abortions, according to the latest Morning Rounds newsletter. The piece notes that the campaign is gaining mom…
    STAT · 27d agoNegative↗ source
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  • Opinion warns post-pandemic polarization may lock in false lessons from Covid response
    The authors, Marc Lipsitch and Sara Cody, argue that the public and policymakers are drawing misleading conclusions from the Covid-19 pandemic. They point out that early nonpharmaceutical interven…
    STAT · 27d agoNegative↗ source
  • Crystalys mines $130M series B to push gout drug through phase 3
    Crystalys Therapeutics has raised $130 million in series B financing to advance the development of its gout drug dotinurad and prepare for a potential commercial launch.
    Fierce Biotech · 26d agoNeutral↗ source
  • Eli Lilly’s $3.8 B bid for AtaiBeckley signals strong pharma endorsement of psychedelics
    Eli Lilly has announced a proposed acquisition of AtaiBeckley valued at up to $3.8 billion. Analysts at H.C. Wainwright described the move as the clearest strategic validation to date of psychedeli…
    BioSpace · 27d agoDealPositive↗ 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 · 28d agoApprovalPositive↗ source
  • Tempus acquires Personalis for $1.5 billion to expand cancer genomics and MRD testing
    Tempus announced it will purchase Personalis in a transaction valued at $1.5 billion, giving it full ownership of the cancer‑genomics firm. The deal builds on a 2023 partnership where Tempus inves…
    Fierce Biotech · 28d 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 · 27d agoDealPositive↗ source
  • Medicare proposes cuts to hospital payments for drugs and imaging under new outpatient rule
    Medicare's Centers for Medicare & Medicaid Services released a proposed rule that would lower the amounts hospitals receive for certain prescription drugs and imaging services provided to Medicare…
    STAT · 27d agoRegulatoryNegative↗ source
  • Vertex’s IgA nephropathy drug povetacicept gains momentum as FDA reviews it after Novartis and Vera approvals
    Vertex Pharmaceuticals’ povetacicept is currently under FDA review with a target action date of Nov. 30 for the treatment of IgA nephropathy. The FDA recently granted full approval to Novartis’ Fa…
    BioSpace · 28d agoRegulatoryPositive↗ source
  • Scribe Therapeutics targets $96 million IPO to fund PCSK9 gene-silencing program
    Scribe Therapeutics, a Bay Area biotech focused on genetic medicines, filed with the SEC outlining plans for an initial public offering on Nasdaq. The company aims to sell 7.1 million shares at $1…
    Fierce Biotech · 28d 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 · 28d 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 · 28d 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 · 28d agoRegulatoryPositive↗ 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 · 27d agoPositive↗ source
  • Axiom Biosciences to launch IPO on Hong Kong exchange before Nasdaq co‑listing
    San Diego‑based Axiom Biosciences announced plans to go public with a primary listing on the Hong Kong Stock Exchange, followed later by a Nasdaq co‑listing, a structure it says is a first for a U.…
    Fierce Biotech · 27d agoDealPositive↗ source
  • FDA’s push to publish complete response letters faces legal uncertainty and possible pause
    The FDA began releasing complete response letters (CRLs) to the public last year, a move promoted as increasing transparency for drug developers, investors, and patients. However, the policy has e…
    BioSpace · 27d agoRegulatoryNegative↗ source
  • Former staff allege LifeMD prioritized GLP-1 prescription volume over patient safety
    Novo Nordisk lists telehealth firm LifeMD on its website as a provider that offers legitimate medicine sourcing and patient support for individuals seeking GLP-1 drugs such as Ozempic and Wegovy.…
    STAT · 27d agoNegative↗ source
  • Veteran scientists launch nonprofit Center for Therapeutic Genetics to advance personalized gene therapies
    A group of experienced researchers from top institutions has created the nonprofit Center for Therapeutic Genetics (CTG) to develop personalized genetic medicines. CTG will operate from a modest s…
    Fierce Biotech · 28d 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 · 28d 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 · 28d agoDealPositive↗ source
  • Bristol Myers Squibb announces construction of pharma’s largest NVIDIA AI supercomputer
    Bristol Myers Squibb (BMS) said it is building what it calls the largest AI supercomputer in the life‑science sector, marking the third such claim by a drugmaker in nine months. The effort expands…
    STAT · 28d agoPositive↗ source
  • BMS partners with Nvidia to build the largest AI supercomputer for drug research
    Bristol Myers Squibb announced an expanded partnership with Nvidia aimed at creating the biggest AI‑driven supercomputing platform for its drug discovery and development work. The new system will…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Former LifeMD staff say company pushed rapid GLP-1 prescriptions at expense of patient safety
    Former employees of telehealth firm LifeMD allege the company encouraged clinicians to see more patients and issue weight‑loss drug prescriptions quickly, with limited screening or follow‑up. Five…
    STAT · 28d agoNegative↗ source
  • Iowa audit finds PBM kept over $100 million by inflating Medicaid drug costs
    A recent audit of Iowa's Medicaid program uncovered that a major pharmacy benefit manager used complex claim handling methods that led to higher costs for the state. The review of records from 201…
    STAT · 28d agoRegulatoryNegative↗ source