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  • Mark Cuban's Cost Plus Drugs targets rare disease market with custom n-of-1 therapies
    Mark Cuban's Cost Plus Drugs, known for low-cost generics, is expanding into rare disease treatments. The company has dedicated part of its new manufacturing plant to producing custom "n-of-1" the…
    STAT · 23d agoPositive↗ source
  • Isomorphic Labs' soaring valuation sparks debate over AI’s impact on drug development and healthcare costs
    Isomorphic Labs, a biotech spin‑out that applies generative AI to design new medicines, recently secured a multi‑billion‑dollar valuation that has captured industry attention. The lofty figure is…
    STAT · 22d agoNeutral↗ source
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FDA device officials prioritize hiring after layoffs, express optimism for upcoming MDUFA VI agreement
Top officials from the FDA's Center for Devices and Radiological Health spoke at a town‑hall session during The MedTech Conference. They said the agency is concentrating on rebuilding staff after a…
raps · 23d agoRegulatoryPositive↗ source
  • ADA chief scientific officer Rita Kalyani departs amid ongoing review of New Orleans incident
    The American Diabetes Association announced Tuesday that its chief scientific and medical officer, Dr. Rita Kalyani, is no longer in her role, effective immediately. The move comes as the ADA cont…
    STAT · 22d agoNegative↗ source
  • Rising US measles cases highlight need for door-to-door public health outreach
    The United States is experiencing its largest measles outbreak in more than 30 years, with over 4,400 confirmed cases and more than a thousand people sickened so far this year. Pennsylvania alone h…
    STAT · 23d agoNegative↗ source
  • Experts suggest emphasizing measles survival rates to boost vaccine trust
    The United States has reported more than 4,400 measles cases this year, roughly twice the number recorded in 2025. At the same time, vaccination rates have fallen in over 1,600 counties between 201…
    STAT · 23d agoNeutral↗ source
  • Pharma companies push FDA for risk-based flexibility in container-closure testing guidance
    Major pharma firms have written to the FDA urging a shift in its current guidance on testing container-closure systems for drug and biologic products. They argue that a risk-based, flexible approa…
    raps · 23d agoRegulatoryNeutral↗ source
  • NIH Scales Back Replication Initiative, Critics Warn It Undermines Scientific Rigor
    NIH originally announced a push to make replication a core part of biomedical research, including an $850,000 Replication Prize launched in March 2025. Health secretary Robert F. Kennedy Jr. sugge…
    STAT · 23d agoNegative↗ source
  • CMS expands fraud crackdown to New York adult day-care program, calls it a "plague to the state"
    CMS announced it will use its new authority to remove providers from federal health programs, focusing on adult day-care centers in New York City. The agency says the Social Adult Day Care (SADC)…
    STAT · 22d agoRegulatoryNegative↗ source
  • FDA approves Hibsago, first antisense therapy for chronic hepatitis B
    The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without…
    fda press · 23d agoApprovalPositive↗ source
  • New drug launch prices climb 35% to $257,000 median, with a quarter exceeding $500,000
    A recent analysis of 202 newly launched medicines shows the median net price jumped 35% last year, reaching $257,000 compared with $173,000 in 2022. The study adjusted prices for inflation and typi…
    STAT · 24d agoRegulatoryNegative↗ source
  • AstraZeneca teams with Oracle on AI-driven clinical trials as FDA clears Haemonetics vascular closure system
    AstraZeneca announced a collaboration with technology firm Oracle to incorporate artificial intelligence into its clinical trial processes. The partnership aims to use Oracle's cloud and data analy…
    raps · 24d agoApprovalPositive↗ source
  • Massachusetts moves to revoke all RegalCare nursing home licenses after Boston Globe investigation
    Massachusetts regulators announced on Oct 13 that they will revoke every nursing home license held by RegalCare, a New Jersey‑based operator that acquired a dozen facilities in the state after the…
    STAT · 23d agoRegulatoryNegative↗ source
  • Roche signs major partnership with China's Hansoh to co-develop antibody-drug conjugates
    Roche announced a deal with China's Hansoh Pharmaceutical Group to develop a portfolio of antibody-drug conjugates (ADCs). The agreement is described as massive, indicating a significant collabora…
    STAT · 23d agoDealPositive↗ source
  • FDA approves first generic weekly hormone patch for menopausal women
    The U.S. Food and Drug Administration has granted approval for a generic version of a once‑weekly transdermal hormone patch that combines estradiol and levonorgestrel. The product matches the brand…
    fda press · 23d agoApprovalPositive↗ source
  • Median net price of new drugs jumps 35% from 2022 to 2025, reaching $257,000
    The Institute for analysis reports that the median net price for 202 newly launched medicines rose 35% between 2022 and 2025 after adjusting for inflation and manufacturer discounts. The median pr…
    STAT · 23d agoNeutral↗ source
  • FDA releases final guidance on prescription-drug companion apps and software
    FDA issued final guidance that creates a clear framework for how drug makers can develop, distribute and label mobile applications that accompany prescription medicines. The document answers three…
    fda press · 23d agoRegulatoryNeutral↗ source
  • Dana-Farber and Beth Israel Lahey Health break ground on $1.68 billion cancer hospital in Boston
    Officials from Dana-Farber Cancer Institute and Beth Israel Lahey Health announced the start of construction on a new dedicated cancer hospital in Boston's Longwood area. The project is budgeted at…
    STAT · 23d agoDealPositive↗ source
  • Midterm ballot measures spotlight abortion, transgender rights and Medicaid expansion
    Voters in the upcoming midterm elections will weigh a series of state ballot questions that address contentious health topics such as abortion access, transgender health care and the expansion of M…
    STAT · 24d agoRegulatoryNeutral↗ source
  • FDA issues import alert on Olympus endoscopic devices over quality violations
    The U.S. Food and Drug Administration has issued an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. The alert applies to…
    fda medwatch · 24d agoRegulatoryNegative↗ source
  • Cardinal Health issues updated instructions for Presource kits containing recalled BD Alaris infusion sets
    The FDA CDRH issued an Early Alert to inform the public of a potentially high‑risk device issue involving Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets linked to a re…
    fda medwatch · 24d agoRegulatoryNegative↗ source
  • Nova Biomedical pulls Gen 2.0 StatStrip hospital glucose meters over patient ID software flaw
    Nova Biomedical has issued a recall of its StatStrip Glucose Hospital Meter System Gen 2.0 model after discovering a software issue that could assign glucose results to the wrong patient. The FDA…
    fda medwatch · 24d agoCRLNegative↗ source
  • FDA issues final guidance on developing and labeling prescription drug apps
    The FDA released its final guidance on Tuesday, outlining how drug sponsors should create, distribute, and label software applications that are used together with prescription medicines. The guida…
    raps · 24d agoRegulatoryPositive↗ source
  • Lawmakers push FDA to close loophole allowing import of counterfeit Eli Lilly obesity drug
    A bipartisan group of U.S. lawmakers is urging the Food and Drug Administration to address a regulatory gap that permits the importation of unapproved versions of retatrutide, an experimental obesi…
    STAT · 23d agoRegulatoryNeutral↗ source
  • Proposed ACGME rule changes could strip resident doctors of mandatory rest periods
    Arifeen Rahman, a clinical instructor in rhinology at the Medical University of South Carolina, recounts working 90-hour weeks as a junior otolaryngology resident in 2023, often exceeding the ACGME…
    STAT · 24d agoRegulatoryNegative↗ source