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  • FDA to replace animal testing terms with broader nonclinical language in regulations
    The U.S. Food and Drug Administration announced it will revise its regulations to replace references to animal testing with broader terms such as "nonclinical tests" and "nonclinical studies". The…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Addiction clinics see rising cases of kratom and 7-OH withdrawal
    Addiction clinics are seeing a surge in patients dependent on potent kratom and 7-OH products.
    STAT · 1mo agoRegulatoryNeutral↗ source
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  • AVID Medical issues correction for convenience kits containing recalled Huons sodium chloride ampules
    AVID Medical has released a correction notice for certain convenience kits that include sodium chloride ampules from Huons Co., which are subject to a recall. The FDA has classified this recall as…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Singapore’s Health Sciences Authority expands regulatory partnerships across Africa, Asia and Europe
    Singapore’s Health Sciences Authority (HSA) announced that it is broadening its regulatory reliance and cooperation framework. The agency is establishing new alliances with regulatory bodies in se…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Experts urge ClinicalTrials.gov to add pregnancy and lactation checkbox to aid trial enrollment
    Patients who are pregnant or nursing often struggle to locate clinical trials that accept them, and clinicians face the same obstacle when advising participants. ClinicalTrials.gov lists more than…
    STAT · 1mo agoPositive↗ source
  • Trump calls for new vaccine while echoing vaccine misinformation
    A recent STAT newsletter reported that President Donald Trump announced he will demand a new vaccine, echoing long-standing vaccine misinformation. The claim was made a day after health secretary R…
    STAT · 1mo agoNegative↗ source
  • STAT launches trust-in-science reporter to explore public skepticism of modern medicine
    STAT has added a new reporter, Nicholas Florko, to cover trust in science and examine why many people doubt modern medicine. Florko, who also deals with personal health issues such as high cholest…
    STAT · 1mo agoNeutral↗ source
  • Republican Iowa governor candidate teams with RFK Jr. as poll lag persists
    Zach Lahn, a farmer and Republican candidate, is running for Iowa governor and currently trails the Democratic opponent in recent polls. Lahn has highlighted his partnership with health secretary…
    STAT · 1mo agoNeutral↗ source
  • Telix to acquire ITM Isotope Technologies in $1.65 billion radiopharma merger
    ITM Isotope Technologies Munich SE and Telix Pharmaceuticals announced a merger that will combine two leading radiopharmaceutical developers. The transaction is valued at a minimum of $1.65 billio…
    STAT · 1mo agoDealNeutral↗ source
  • Jehovah's Witnesses ease ban, permitting blood-derived products while still forbidding whole-blood transfusions
    The religious group announced a revision to its long-standing medical policy, now allowing members to receive products derived from donated blood. The new guidance says individuals may accept plas…
    STAT · 1mo agoNeutral↗ source
  • Roche opens new research center in Boston, expanding its local presence
    Roche announced the opening of a new research facility in Boston, adding to its existing operations in the city. The center will focus on early-stage drug discovery and will house several hundred…
    STAT · 1mo agoPositive↗ source
  • Trump announces GENEROUS model, securing pharma deals to cut Medicaid drug prices
    President Trump announced a new initiative called the GENEROUS model that is intended to lower drug prices for state Medicaid programs. The program will involve all 50 states, Washington, D.C., an…
    STAT · 1mo agoDealNeutral↗ source
  • U.S. drafts new investment rules to keep pharma licensing deals with China viable
    The United States is drafting new guidelines that would govern how American investors can fund Chinese biotech and pharmaceutical companies. The proposed framework is intended to address national‑s…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Sudan civil war forces cancer patients to endure hazardous journeys for treatment
    Medical missionary Tom Catena has run the Mother of Mercy hospital in the Nuba Mountains for over a decade, but the ongoing civil war has crippled Sudan’s health system. The remote facility, the la…
    STAT · 1mo agoNegative↗ source
  • Spectra Medical recalls Sodium Chloride Flush ampules due to serious safety risk
    Spectra Medical Devices has issued a recall of its Sodium Chloride Injection 0.9% USP 10 mL flush ampules that were manufactured by Huons Co., Ltd. The FDA classified the recall as the most serious…
    fda medwatch · 1mo agoCRLNegative↗ source
  • HCA Healthcare sues Independence Blue Cross over $345,000 in unpaid Texas hospital claims
    Several Texas hospitals owned by HCA Healthcare have filed a lawsuit against Independence Blue Cross, a Philadelphia‑based insurer, seeking more than $345,000 in unpaid medical claims dating back r…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA faces nominee hearing, hiring woes and reviews of psychedelics and testosterone therapies
    A Senate committee set a hearing for President Trump's pick to lead the FDA, highlighting the political scrutiny of the agency's top leadership. New reporting reveals ongoing hiring challenges at…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Doctors urged to tell patients Asian glow signals health risk, not harmless quirk
    Brian Zhang, a second-year medical student at Stanford and student body president, wrote an opinion piece urging doctors to discuss the so-called "Asian glow" with patients. The facial flushing th…
    STAT · 1mo agoNeutral↗ source
  • FDA updates instructions for NOxBOXi nitric oxide delivery system after leak risk identified
    The FDA has issued a correction for the NOxBOXi nitric oxide delivery system with the NOxMixer module after discovering that the device can leak oxygen during inhaled nitric oxide therapy. The age…
    fda medwatch · 1mo agoCRLNeutral↗ source
  • Panel discusses how questions about health equity shape public trust in science
    Anil Oza reported that he participated in a National Academies of Science roundtable focused on population health and how research communication influences public trust. The discussion highlighted…
    STAT · 1mo agoNeutral↗ source
  • IN8bio appoints Oxana Polyakova as senior vice president of R&D
    IN8bio announced a new senior vice president for research and development. Oxana Polyakova joins the company after serving as chief scientific officer at LAVA Therapeutics. Her background in drug…
    STAT · 1mo agoPositive↗ source
  • Geriatrician urges careful use of AI predictions for older patients
    Artificial intelligence tools are being added to electronic health records to flag patients at risk for conditions such as sepsis, falls or even death. The ease of integration has led many clinicia…
    STAT · 1mo agoNeutral↗ source
  • Rise in Young Men Seeking Cosmetic Surgery Driven by Social Media Influence, Surgeon Observes
    A board‑certified plastic surgeon in Boston reports that more young men are now filling her waiting room than ever before, making men the fastest‑growing group in aesthetic procedures. Procedures…
    STAT · 1mo agoNeutral↗ source
  • FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known…
    fda press · 1mo agoApprovalPositive↗ source
  • England's NHS to fund AstraZeneca's Enhertu for metastatic breast cancer after U.K.-U.S. pricing pact
    English health authorities have agreed to provide AstraZeneca's breast cancer drug Enhertu through the NHS, ending a multi-year dispute over its availability. The decision will make the drug acces…
    STAT · 1mo agoDealPositive↗ source