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1,177 stories matching this filter · ← front page

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  • Publix recalls all GreenWise Organic frozen blueberries and mixed berries over potential E. coli O145 contamination
    Publix announced a recall of all lots of GreenWise Organic Whole Blueberries and Whole Mixed Berries because the products may be contaminated with Escherichia coli O145:H28. The strain is a Shiga…
    fda recalls · 3d agoCRLNegative↗ 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 · 3d agoApprovalPositive↗ source
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  • FDA finds Capricor's Duchenne stem cell therapy failed to meet Phase 3 goals, contradicting company claims
    The U.S. Food and Drug Administration announced that the stem cell treatment from Capricor Therapeutics did not achieve the primary objectives in its Phase 3 trial for Duchenne muscular dystrophy.…
    STAT · 3d agoRegulatoryNegative↗ source
  • FDA finds Replimune's melanoma data package uninterpretable, foreshadows tough advisory committee review
    The FDA has deemed the single-arm mid-stage study submitted by Replimune for its oncolytic immunotherapy RP1 as not interpretable, raising concerns ahead of an upcoming advisory committee meeting.…
    BioSpace · 3d agoRegulatoryNegative↗ source
  • Apnimed targets up to $160 million IPO to fund sleep‑apnea drug AD109
    Apnimed, a sleep‑specialist biotech, announced plans for an initial public offering that could raise up to $160 million in gross proceeds. The company will sell 10 million shares at $14‑$16 each,…
    BioSpace · 3d agoDealPositive↗ source
  • GSK launches $2.5 billion restructuring plan to fund late-stage pipeline and offset upcoming HIV drug patent loss
    GSK reported $2.4 billion in impairment charges for the second quarter and unveiled a three‑year restructuring designed to save roughly $2.5 billion. The company says the savings will be redirecte…
    BioSpace · 3d agoPositive↗ source
  • GSK CEO outlines £1.9bn cost-saving drive and aims to launch 20 Phase 3 trials by year-end
    GSK chief executive Luke Miels presented a three‑year plan to make the company more agile and generate significant cost efficiencies. The strategy targets £1.9 billion in annual savings by 2029, wi…
    STAT · 3d agoPositive↗ source
  • FDA staff raise concerns over Replimune's skin cancer drug data
    FDA staff have reiterated concerns that Replimune's investigational skin cancer therapy lacks sufficient data for approval. The agency highlighted the single-arm trial, in which patients previousl…
    STAT · 3d agoRegulatoryNegative↗ source
  • Altimmune's pemvidutide cuts heavy drinking days in Phase 2 trial
    Altimmune reported that its experimental GLP-1/GIP injection pemvidutide achieved its primary and key secondary goals in a Phase 2 study of alcohol use disorder. The double-blind trial enrolled 10…
    BioSpace · 3d agoPositive readoutPositive↗ source
  • Oak Hill Bio to go public via SPAC merger, securing $175 million for Angelman syndrome program
    Oak Hill Bio announced it will become a publicly traded company through a merger with the special purpose acquisition company Research Alliance Corporation III. The transaction will provide $75 mi…
    BioSpace · 3d agoDealPositive↗ source
  • Trump administration proposes four-year visa cap for foreign PhD students and postdocs, sparking science community concerns
    The Department of Homeland Security announced a new rule that limits the stay of international graduate students and postdoctoral researchers in the United States to four years on nonimmigrant visa…
    STAT · 3d agoRegulatoryNegative↗ 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 · 4d 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 · 4d 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 · 4d 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 · 4d agoRegulatoryNeutral↗ source
  • Opinion: STAT+: Dementia finally has a business model
    The big takeaway from the recent Alzheimer’s Association International Conference in London is an economic message: Dementia finally has a business model, writes Jason Karlawish.
    STAT · 4d agoRegulatoryNeutral↗ source
  • STAT+: From ‘lost cause’ to gold rush: Biotechs swarm to cure AATD
    Biotech companies are racing to cure alpha-1 antitrypsin deficiency, AATD, fueling patent disputes, startup defections, arbitration, and a U.S.-China rivalry.
    STAT · 4d agoRegulatoryNeutral↗ source
  • STAT+: CMS evaluates one year of health tech progress, announces eight new pledge categories
    One year after launching the CMS Health Tech Ecosystem, officials convened in D.C. to celebrate the Trump administration modernizing health technology.
    STAT · 4d agoRegulatoryNeutral↗ source
  • ADA faces member backlash and calls for CEO and CSO resignations after expert expulsions
    The American Diabetes Association’s 2026 Scientific Sessions in New Orleans ended with the expulsion of five diabetes experts, sparking a wave of criticism. More than 200 members signed an open le…
    STAT · 3d agoNegative↗ source
  • Webinar Explores AI-Driven Intelligence Engine for Optimizing Antibody, ADC and Peptide Candidates
    Drug discovery teams are grappling with an ever‑growing volume of data, and converting that data into actionable insight remains a key hurdle. In a recent BioSpace webinar, Patsnap’s Ben Coverdale…
    BioSpace · 3d agoNeutral↗ source
  • Anthony Fauci scheduled to testify before Senate Homeland Security Committee
    Anthony Fauci has been subpoenaed to appear before the Senate Homeland Security Committee for a new testimony. The hearing is scheduled for tomorrow and will focus on issues related to the federal…
    STAT · 3d agoRegulatoryNeutral↗ source
  • WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status
    The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…
    raps · 4d agoRegulatoryNeutral↗ source
  • Senate Republicans, led by Rand Paul, compel Dr. Fauci to testify at hearing on COVID-19 response
    Senate Republicans, especially Rand Paul, have long criticized the government’s handling of the COVID-19 pandemic and are using a Senate hearing to question Dr. Anthony Fauci. Paul, who has accuse…
    STAT · 3d agoRegulatoryNeutral↗ source
  • CDC survey shows racial gaps in diagnosis of endometriosis, PMOS and uterine fibroids among US women
    A recent CDC National Center for Health Statistics report based on a 2022-2023 survey of about 5,000 women ages 20 to 49 provides new insight into how often certain gynecologic conditions are diagn…
    STAT · 3d agoNeutral↗ source
  • Whoop appoints new chief medical officer, discusses health tech plans and CMS initiative
    STAT Health Tech’s latest newsletter features a brief interview with Whoop’s newly appointed chief medical officer. The CMO fielded three questions about the company’s direction, wearable data use…
    STAT · 3d agoNeutral↗ source