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1,187 stories matching this filter · ← front page

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  • Former VA Secretary argues the Veterans Health Administration can boost US biotech competitiveness against China
    The piece, authored by former Veterans Affairs Secretary David Shulkin, positions the VA as a critical component of America’s biotechnology ecosystem alongside HHS and the Department of Defense. H…
    STAT · 1h agoNeutral↗ source
  • Biotech earnings season kicks off as Agios reports Phase 2 setback for sickle-cell drug
    The second‑quarter earnings window has begun, and analysts are zeroing in on a handful of biotech companies with high‑profile catalysts. Smaller biotechs are increasingly opting to launch their pr…
    BioSpace · 5h agoNegative readoutNeutral↗ source
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  • Prolonged hospital stays leave children isolated, urging change
    An author visiting a pediatric ward describes a young, nonverbal child with severe developmental delays who has been waiting months for a life-saving liver transplant. The child lies in a stark, ma…
    STAT · 1h agoNegative↗ source
  • Most-wanted fugitive Ronald Fischer operated under alias in biotech industry for two decades
    A Rhode Island man on the most-wanted list was recently uncovered as a hidden employee in the biotech sector, having worked under a false identity for about twenty years. The individual, identifie…
    STAT · 1h agoNegative↗ source
  • STAT+: Clinical chatbots are taking medicine by storm. Should doctors trust them?
    As LLMs compete for doctors' attention, some developers say the science of benchmarking their AI tools for safety and accuracy is flawed.
    STAT · 1h ago↗ source
  • Visa time limits on foreign Ph.D. students and postdocs will harm U.S. science, experts warn
    A Trump administration plan to limit visas for graduate student and postdocs to four years is fueling concerns that the U.S. could lose out on foreign scientists
    STAT · 16h agoApprovalPositive↗ source
  • FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
    The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy.
    BioSpace · 20h agoApprovalPositive↗ source
  • STAT+: Preliminary trial results suggest a path to a safer Alzheimer’s treatment
    ProMIS Neurosciences is trying to design a safer amyloid-clearing drug for Alzheimer's. Early results suggest it might be on to something.
    STAT · 23h agoApprovalPositive↗ source
  • GSK shares rise as $2.5B cost-cutting plan unveiled
    As GSK records $2.4 billion in impairment charges for the second quarter, the U.K. pharma has announced a sweeping restructure designed to save about the same amount of money over the next few years.
    BioSpace · 19h agoLayoffsNegative↗ source
  • Boston Scientific unveils major restructuring, plots job cuts amid savings drive
    Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally.
    Fierce Biotech · 1d agoLayoffsNegative↗ source
  • As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
    When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
    BioSpace · 1d agoDealNeutral↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 1d agoRegulatoryNeutral↗ source
  • Webinar: Building the Intelligence Engine for Drug Discovery R&D Teams
    Drug discovery teams have more data than ever, but turning that data into actionable insight remains a major challenge. In this candid conversation, Patsnap’s Ben Coverdale is joined by Mark Davies…
    BioSpace · 12h agoRegulatoryNeutral↗ source
  • Six key issues we’re watching at Fauci’s hearing
    Sen. Rand Paul is forcing Fauci to appear before his Senate panel.
    STAT · 14h agoRegulatoryNeutral↗ source
  • STAT+: Bracing for another Fauci hearing
    Plus: Democrats take on Trump over IVF, and Trump's White House releases a new science funding blueprint.
    STAT · 17h agoRegulatoryNeutral↗ source
  • STAT+: GSK lays out plans to cut costs, pursue more late-stage drug trials
    New GSK CEO Luke Miels outlined his strategy to help the company navigate a patent cliff and get on a path toward long-term growth.
    STAT · 19h agoRegulatoryNeutral↗ source
  • STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment
    Regulators at the FDA have reiterated concerns that Replimmune does not have adequate data to support an approval of its investigational skin cancer treatment.
    STAT · 20h agoRegulatoryNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and more
    The FDA said a Capricor stem cell treatment for Duchenne muscular dystrophy did not meet a Phase 3 trial's objectives — contrary to company claims
    STAT · 20h agoRegulatoryNeutral↗ source
  • STAT+: Three questions with Whoop’s new CMO
    In this edition of STAT Health Tech: A chat with Whoop's new chief medical officer, an update on CMS health tech initiative, and more.
    STAT · 20h agoRegulatoryNeutral↗ source
  • Altimmune rises as GLP-1/glucagon drug curbs heavy drinking in mid-stage study
    Pemvidutide showed a “highly statistically significant” treatment effect in patients with alcohol use disorder. Altimmune is going up against Eli Lilly and newcomer Baseline Therapeutics, among oth…
    BioSpace · 21h agoRegulatoryNeutral↗ source
  • Anthony Fauci’s pandemic-era diary entries
    New data on American substance use, concerns of a global HIV resurgence, and more health news from Morning Rounds
    STAT · 22h agoRegulatoryNeutral↗ source
  • Apnimed eyes up to $160M IPO to prep for sleep apnea drug launch
    If the offering closes, Apnimed will join the 2026 IPO class that has already far surpassed last year’s total.
    BioSpace · 22h agoRegulatoryNeutral↗ source
  • Oak Hill takes SPAC track to Nasdaq with Roche asset in tow
    Oak Hill Bio is developing the antisense therapy rugonersen, which it licensed from Roche in 2025, for Angelman syndrome.
    BioSpace · 22h agoRegulatoryNeutral↗ source
  • After PCOS became PMOS, there’s hope for new awareness among Black and Latina women
    Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.
    STAT · 1d agoRegulatoryNeutral↗ source