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  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 3mo agoApprovalPositive↗ 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 · 3mo agoRegulatoryNegative
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  • 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 · 3mo agoNegative readoutNegative↗ source
  • Sonothera reports ultrasound method delivers high levels of dystrophin in monkeys, a potential new route for Duchenne therapy
    A California startup, Sonothera, is proposing an ultrasound‑based approach to deliver genes for Duchenne muscular dystrophy treatment. The company says its technology can introduce full-size dystr…
    STAT · 3mo agoPositive readoutNeutral↗ source
  • Medicare proposal would boost doctor pay for smoking and alcohol counseling by 19%
    A proposed change to Medicare’s physician fee schedule would increase reimbursement for doctors who provide counseling on tobacco cessation and alcohol or substance misuse. The proposal adds a 19%…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Jasper Therapeutics secures $132 million and merges with Kira Pharmaceuticals to revive pipeline
    Jasper Therapeutics, a cash‑strapped biotech, announced it completed an all‑stock acquisition of privately held immune‑drug developer Kira Pharmaceuticals. The merger is paired with a private stoc…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Arbutus and Sanofi launch new patent lawsuits against Pfizer, BioNTech and Moderna over mRNA lipid nanoparticle technology
    Arbutus BioPharma filed three new lawsuits against Pfizer and BioNTech, accusing them of infringing patents covering the lipid nanoparticle (LNP) technology used to deliver mRNA vaccines. The filin…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • U.S. drug shortages climb to 227 active cases in Q2 2026
    The United States reported a rise in active medication shortages during the second quarter of 2026, with the total reaching 227. The increase signals growing pressure on the pharmaceutical supply…
    STAT · 3mo agoNeutral↗ source
  • AI-discovered drugs show early promise but face mixed results in clinical trials
    AI is being promoted as a way to cut the cost and time of drug research and development, which can exceed $2.6 billion and take up to 15 years. Only a handful of AI‑identified compounds have enter…
    BioPharma Dive · 3mo agoNeutral↗ source
  • MDCalc introduces quality-rating system for over 800 clinical calculators used by doctors
    MDCalc, a health‑technology company, announced a new quality‑rating system that will evaluate the more than 800 clinical calculators doctors rely on for decisions such as kidney function, birth out…
    STAT · 3mo agoPositive↗ source
  • CDC links Taco Bell lettuce in five states to cyclospora outbreak
    Federal health officials have identified shredded iceberg lettuce from Mexico served at Taco Bell restaurants in Indiana, Kentucky, Michigan, Ohio and West Virginia as the source of a widespread cy…
    STAT · 3mo agoRegulatoryNegative↗ source
  • GSK discontinues its chronic cough therapy amid uncertain future
    GSK has announced that it is ending development of its chronic cough treatment. The decision marks the conclusion of the program that had been under investigation for several years. The article do…
    STAT · 3mo agoNegative↗ source
  • Sonothera touts ultrasound gene-delivery platform for Duchenne, but experts remain skeptical
    Sonothera, a California startup, says its ultrasound‑based technology can deliver therapeutic genes into cells, a method it believes could treat Duchenne muscular dystrophy and other genetic disord…
    STAT · 3mo agoNeutral↗ source
  • Opinion: MAHA pushes psychiatric deprescribing agenda, reshaping mental-health language
    Sunny Patel, an associate professor of psychiatry and pediatrics at Georgetown University, critiques the Mental Health Advocacy (MAHA) movement in a recent opinion piece. He notes her background wi…
    STAT · 3mo agoNegative↗ source
  • Ichnos Glenmark Innovation appoints Mariana Cota Stirner as chief medical officer
    Ichnos Glenmark Innovation announced the appointment of a new chief medical officer. Mariana Cota Stirner will assume the role, bringing experience from her recent position as fractional chief med…
    STAT · 3mo agoNeutral↗ source
  • Canadian wildfires drive NYC asthma ER visits up 31% as heat wave intensifies haze
    Recent Canadian wildfires have produced massive smoke plumes that have drifted into the United States, degrading air quality across many cities. In New York City, emergency department visits for a…
    STAT · 3mo agoNeutral↗ source
  • Trump administration moves to restore LGBTQ+ youth counseling on 988 line amid concerns over trans identity exclusion
    Specialized counseling services for LGBTQ+ youth are slated to return to the 988 Suicide & Crisis Lifeline by the end of the year, according to a recent confirmation from the Trump administration.…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Taylor Fresh Foods recalls all iceberg lettuce from central Mexico over possible Cyclospora contamination
    Taylor Fresh Foods, operating as Taylor Farms de Mexico in Guanajuato, is voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market because of a potential Cyclospora…
    fda recalls · 3mo agoCRLNegative↗ source
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion, adding late-stage depression drug
    Eli Lilly announced it will acquire New York‑based biotech AtaiBeckley in a transaction valued at about $2.8 billion. The agreement sets the purchase price at $6.75 per share, a 26 % premium to At…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Merck's Lipfendra pill receives FDA approval as first oral PCSK9 cholesterol treatment
    The U.S. Food and Drug Administration approved Lipfendra, an oral medication from Merck that lowers low density lipoprotein cholesterol. The drug blocks the PCSK9 protein, making it the first pill…
    BioPharma Dive · 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
  • 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
  • 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
  • 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
  • Veradermics' experimental hair loss pill shows promising results in women
    Veradermics reported positive Phase 2 data for its oral minoxidil formulation VDPHL01 in women with mild-to-moderate pattern hair loss. The study enrolled 28 participants who took the drug once or…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source