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  • European Commission publishes guideline on transparency obligations under AI Act
    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, in…
    raps · 9d ago↗ source
  • Tempus to acquire cancer test maker Personalis for $1.5B
    Tempus AI’s planned acquisition follows recent interest in blood-based cancer tests across the medtech industry.
    BioPharma Dive · 9d ago↗ source
  • Tempus to buy cancer test-maker Personalis for $1.5B
    Tempus AI’s planned acquisition follows recent interest in blood-based cancer tests across the medtech industry.
    BioPharma Dive · 9d ago↗ source
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  • Pain drugmaker Latigo outlines plans to go public
    The Westlake-founded company specializes in non-opioid drugs that target sodium ion channels, and is now adding to what’s already been a busy month for the biotech IPO queue.
    BioPharma Dive · 10d 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 · 10d 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 · 10d ago↗ source
  • Bristol Myers to build ‘powerful’ AI factory; Samsung Biologics bids for peptide maker
    Bristol Myers is the third pharmaceutical company to recently seek Nvidia’s help building a large AI data center. Elsewhere, a Novartis kidney drug gained a leg up on competitors.
    BioPharma Dive · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d ago↗ source
  • Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5B
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 10d ago↗ source
  • Asia-Pacific Roundup: TGA seeks feedback on Australian regulations for digital mental health tools
    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to inform changes to the regulatory framework for digital mental health tools (DMHTs).
    raps · 10d ago↗ source
  • Study: China outpaces the US in cancer approvals, lags behind on first approvals
    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 fi…
    raps · 10d ago↗ source
  • MHRA touts uptick in approvals in 2025-2026 annual report
    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 tha…
    raps · 10d ago↗ source
  • Jasper gets a lifeline in merger with immune drugmaker Kira
    The acquisition, which involves a concurrent licensing deal with startup Mirador, gives Jasper a chance to rebound from setbacks that have wiped out most of its market value.
    BioPharma Dive · 13d ago↗ source
  • FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
    The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduc…
    fda press · 13d 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 · 13d ago↗ source
  • Arbutus, Sanofi escalate mRNA patent fights; InnoCare’s TYK2 contender advances
    The new lawsuits add to a web of legal disputes over technology involved in COVID vaccines. Elsewhere, a prolific AI biotech inked another deal and Insmed strengthened support for a closely watched…
    BioPharma Dive · 13d ago↗ source
  • Compounders maintain a firm grip on the GLP-1 market
    Despite an FDA crackdown, numerous pharma lawsuits and possible safety risks, nearly 1 in 5 patients are still taking cheaper weight-loss alternatives.
    BioPharma Dive · 13d ago↗ source
  • GSK shelves cough drug acquired in $2B deal
    Mixed Phase 3 data for camlipixant prompted the British pharma to cease development, making the drug the third from its class to fail.
    BioPharma Dive · 13d ago↗ source
  • How well are AI-discovered drugs faring in the clinic?
    Some of the industry’s most closely-watched AI drugs could provide insight into the success of technology-assisted development.
    BioPharma Dive · 13d 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 · 13d 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 · 13d 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 · 13d ago↗ source