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2,189 stories matching this filter · ← front page

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  • FDA says former officials' journal articles do not represent agency policy after lawmaker criticism
    Acting FDA director Kyle Diamantas wrote to House Energy & Commerce ranking member Diana DeGette, stating that journal papers authored by former agency officials do not convey FDA policy or regulat…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • GSK halts Phase 3 chronic cough drug camlipixant, jeopardizing $2 billion Bellus Health acquisition
    GSK announced it is ending development of camlipixant, a drug aimed at treating refractory chronic cough, after completing Phase 3 trials. The move comes as the company proceeds with its planned $…
    Endpoints · 1mo agoNegative↗ source
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  • 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 · 1mo agoPositive↗ source
  • Bolton Medical Issues Urgent Recall of Relay Pro Thoracic Stent Graft Over Unclasping Fault
    Bolton Medical announced an urgent Class I recall of its Relay Pro Thoracic Stent Graft System, specifically the non-bare stent configuration 32 mm and larger. The recall was triggered because the…
    fda medwatch · 1mo agoCRLNegative↗ 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 · 1mo 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 · 1mo agoNegative↗ source
  • Dimerix acquires Mission’s acute kidney injury candidate for $5 million upfront
    Dimerix announced it has signed a deal to acquire a kidney injury drug candidate from Mission Therapeutics. The asset is ready to enter Phase 2 trials for the treatment of acute kidney injury. Und…
    Endpoints · 1mo agoDealPositive↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoNeutral↗ source
  • Zealand Pharma appoints former Lilly executive as US marketing head
    Silvia Luque announced on LinkedIn that she will lead US marketing for Zealand Pharma. The appointment follows a 13-year tenure at Eli Lilly, where she held several roles in the company's obesity f…
    Endpoints · 1mo 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 · 1mo agoRegulatoryNegative↗ source
  • 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 · 1mo 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 · 1mo 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 · 1mo agoDealPositive↗ source
  • Merck secures US approval for the first oral PCSK9 cholesterol-lowering pill, edging out AstraZeneca
    Merck has received the United States regulatory clearance for an oral PCSK9 inhibitor, marking the first time a pill of this class has been approved for cholesterol management. The approval comes…
    Endpoints · 1mo 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 · 1mo 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 · 1mo agoEarningsNegative↗ source
  • US drug shortages climb for third consecutive quarter, many rely on single suppliers
    The latest data show that the count of medicines in shortage across the United States increased again in the most recent quarter, marking the third straight period of growth. Analysts note that ne…
    Endpoints · 1mo agoNegative↗ 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 · 1mo agoLayoffsNegative↗ source
  • Mirador Therapeutics announces partnership to acquire Kira drug, positioning it against Tavneos
    Mirador Therapeutics, a San Diego‑based biotech focused on immune diseases and backed by more than $650 million in venture capital, has disclosed a new element of its development pipeline. The com…
    Endpoints · 1mo agoDealPositive↗ 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 · 1mo 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 · 1mo agoPositive readoutPositive↗ source
  • Alzheimer researcher Betty Tijms urges broader view beyond amyloid and tau
    Betty Tijms, head of science at the Alzheimer Center Amsterdam, says it is time to stop treating Alzheimer’s as a single disease. For more than a century, research has focused on two proteins, amy…
    Endpoints · 1mo agoNeutral↗ source