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  • Merck wins FDA nod for first oral PCSK9 inhibitor, Lipfendra, to treat high LDL cholesterol
    Merck announced that the U.S. Food and Drug Administration has approved its once-daily oral PCSK9 inhibitor, enlicitide, marketed as Lipfendra, for adults with elevated LDL cholesterol. The drug i…
    BioSpace · 3mo agoApprovalPositive↗ source
  • FDA approves Merck’s first oral PCSK9 inhibitor, marking a first for the drug class
    The U.S. Food and Drug Administration has granted approval to Merck for its oral PCSK9 inhibitor, the first drug of this type to receive such clearance. The approval represents a milestone because…
    STAT · 3mo agoApprovalPositive↗ source
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Nephrology760
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion
    Eli Lilly announced it will acquire AtaiBeckley, a biotech focused on psychedelic therapies for mental health, for an upfront cash payment of $2.8 billion. The purchase adds a new dimension to Lil…
    STAT · 3mo agoDealPositive↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 3mo agoApprovalPositive↗ source
  • Eli Lilly to acquire AtaiBeckley in up to $3.8 billion deal, entering psychedelics market
    Eli Lilly announced it will buy AtaiBeckley, offering $6.75 per share for the company’s common stock. The transaction includes an upfront commitment of about $2.8 billion and a contingent value rig…
    BioSpace · 3mo agoDealPositive↗ source
  • UnitedHealth beats Q2 forecasts but warns rising insurance costs will strain employers
    UnitedHealth Group reported second-quarter results that exceeded analysts' expectations, lifting its shares modestly. Despite the upbeat earnings, executives highlighted that medical expenses for…
    STAT · 3mo agoEarningsNegative↗ source
  • Biopharma layoffs may exceed 14,000 jobs in H1 as Takeda, BioNTech and Viatris cut staff
    Biopharma firms are preparing for a wave of job cuts in the first half of 2026, with total layoffs projected to affect more than 14,000 employees, according to data compiled by BioSpace. The bulk…
    BioSpace · 3mo agoLayoffsNegative↗ source
  • Republicans block bill to end Medicare AI prior-authorization pilot
    A Senate vote on Thursday failed to halt a Medicare pilot that uses artificial intelligence to approve or deny care. The measure, backed by Democrats, was rejected by a 46‑to‑50 vote, with Republic…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Brain implant gives touch sensation back to man with quadriplegia
    Keith Thomas, a 48-year-old who lost feeling and movement below his neck after a diving accident in 2020, received a brain-computer interface implant in 2023 as part of an experimental study. The…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Medicare proposes overhaul of payment models for clinical AI and remote patient monitoring
    The Centers for Medicare and Medicaid Services (CMS) has announced a set of proposals aimed at reshaping how Medicare reimburses clinical artificial intelligence tools and remote patient monitoring…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • FDA issues first AI-focused cGMP warning letter, flagging oversight gaps for manufacturers
    The FDA has issued its first warning letter that explicitly addresses the use of artificial intelligence in pharmaceutical manufacturing, targeting Purolea Cosmetics Lab. The letter cites AI‑gener…
    BioSpace · 3mo agoRegulatoryNegative↗ source
  • Three biotech firms launch IPOs to challenge giants in cardiometabolic and immunology markets
    Braveheart Bio, Attovia Therapeutics and Vogenx filed for initial public offerings this week, adding to a surge of biotech listings in 2026. Braveheart is developing a therapy for hypertrophic car…
    BioSpace · 3mo agoDealNeutral↗ source
  • Podcast explores non-opioid and regenerative approaches to pain relief
    In a recent episode of the Denatured podcast, Lance Alstodt, chairman and CEO of BioRestorative Therapies, and Paul Mieyal, chief business officer of South Rampart Pharma, discuss why pain remains…
    BioSpace · 3mo agoPositive↗ source
  • J&J reports 40% Q2 sales jump for Spravato as psychedelic rivals loom
    Johnson & Johnson said its depression nasal spray Spravato generated $584 million in worldwide revenue in the second quarter, a 40% increase from a year earlier. The company highlighted the drug as…
    BioSpace · 3mo agoEarningsNeutral↗ source
  • Amylyx to read out pivotal endocrine drug study results later this quarter
    Amylyx Pharmaceuticals will read out results later this quarter from a study of a new treatment for a rare endocrine disorder. The drug, avexitide, is being developed to prevent severe, uncontroll…
    STAT · 3mo agoNeutral↗ source
  • CMS proposes new payment framework for clinical software and AI to link reimbursement with patient outcomes
    The Centers for Medicare & Medicaid Services (CMS) has released proposed rules for 2027 that would create a standardized payment structure for clinical software and artificial intelligence tools. T…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authority
    Stakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments. They warned that any new repurpos…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Podcast highlights prediction markets entering biotech and Biogen Alzheimer's drug controversy
    The Readout LOUD episode released on July 16, 2026 features hosts Elaine Chen, Adam Feuerstein and Allison DeAngelis. The trio discuss trends shaping biotech, from new obesity treatments to evolvin…
    STAT · 3mo agoNeutral↗ source
  • Kalshi to Offer Prediction Market Bets on Clinical Trials and Regulatory Approvals
    Kalshi, one of the world’s largest prediction‑market exchanges, announced it will start allowing bets on the outcomes of clinical trials and regulatory approvals. The initiative could give investor…
    STAT · 3mo agoNeutral↗ source
  • Kalshi launches prediction markets for clinical trial results and FDA approvals
    Kalshi, a major prediction market exchange, announced it will begin offering markets that let participants bet on the outcomes of clinical trials and on whether drugs will receive FDA approval. Th…
    STAT · 3mo agoPositive↗ source
  • Venom’s hidden potential fuels next wave of peptide medicines beyond GLP-1 weight-loss drugs
    Steve Midway, an associate professor at LSU, argues that many powerful medicines already exist in the venoms of feared creatures, noting that venom contributed to the development of GLP-1 based wei…
    STAT · 3mo agoPositive↗ source
  • Medicaid and SNAP cuts deepen hunger and mental health crises, clinicians warn
    Cole Hanson, a clinical dietitian at a large urban hospital, writes about the direct link he sees between food insecurity and psychiatric emergencies. He recounts a patient who arrived with suicid…
    STAT · 3mo agoRegulatoryNegative↗ source
  • EMA issues guidance to curb microbial contamination in non-sterile medicines; MHRA reports record drug approvals
    The European Medicines Agency has issued new guidance that outlines technical and organisational measures to reduce the risk of microbial contamination in non-sterile pharmaceutical products. The…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Senate health committee hears testimony from Trump pandemic preparedness nominee amid daylight-saving debate
    The Senate health committee convened a hearing where the president’s pandemic preparedness nominee provided testimony on readiness measures. Lawmakers also debated proposals to make daylight savin…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps toward AI oversight in healthcare
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines this year than in t…
    raps · 3mo agoRegulatoryNeutral↗ source