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4,131 stories matching this filter · ← front page

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  • 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 · 19d agoNeutral↗ source
  • Samsung Biologics union vows appeal after court blocks planned strike
    A Seoul court granted Samsung Biologics an order that prevents its labor union from holding a strike that had been scheduled for the company's bio-manufacturing campus. The union, representing con…
    Endpoints · 20d agoNegative↗ 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 · 20d 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 · 19d agoNegative↗ source
  • Endpoints AI Day highlights agents, AI slop and biosecurity gaps in pharma
    Endpoints News held its third AI Day, an event dedicated to exploring how artificial intelligence can be applied across drug discovery and development. Speakers, including Nathan Frey of Anthropic…
    Endpoints · 20d agoNeutral↗ 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 · 20d 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 · 20d 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 · 20d 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 · 20d 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 · 19d 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 · 20d agoApprovalPositive↗ source
  • Rapport Therapeutics' epilepsy drug RAP-219 meets primary endpoint in bipolar mania Phase II trial
    Rapport Therapeutics reported that its experimental pill RAP-219, originally developed for epilepsy, was tested in a mid‑stage study of adults with bipolar mania. The trial enrolled roughly 250 par…
    BioPharma Dive · 21d agoPositive readoutPositive↗ source
  • ICER reports two-thirds of new drugs launched 2022-2025 priced well above cost-effectiveness thresholds
    ICER’s latest analysis of launch prices for new prescription medicines shows a sharp rise in net costs between 2022 and 2025. After adjusting for inflation, the median price climbed from $190,000 i…
    BioPharma Dive · 21d agoNegative↗ source
  • Biopharma Sentiment Index climbs to upbeat 105 in Q3 2026, marking strongest optimism in years
    Endpoints Signal released its Q3 2026 Biopharma Sentiment Index, showing a dramatic lift in industry mood. The survey indicates the sector is finally in a positive territory after a four-year downt…
    Endpoints · 21d agoPositive↗ 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 · 21d 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 · 21d 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 · 20d agoRegulatoryNegative↗ source
  • ICER report finds median launch drug prices jumped 24% between 2022 and 2025
    The Institute for Clinical and Economic Review released a new analysis showing that the median list price of newly launched drugs increased by 24% from 2022 to 2025. The report also notes that net…
    Endpoints · 20d agoNegative↗ 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 · 21d 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 · 21d agoApprovalPositive↗ source
  • Pfizer halts Phase 2 trial of PF-06835375 in primary immune thrombocytopenia
    Pfizer announced that it is stopping its Phase 2 study of the experimental program PF-06835375, which was being evaluated in patients with primary immune thrombocytopenia, a rare autoimmune blood d…
    Endpoints · 21d agoNegative readoutNegative↗ 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 · 21d 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 · 21d 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 · 21d agoDealPositive↗ source
  • Pharma pours billions into bispecifics, ADCs and cell therapies despite limited clinical proof
    The article notes that emerging drug formats such as bispecific antibodies, antibody‑drug conjugates and cell therapies have yet to demonstrate clear clinical success, yet pharmaceutical firms cont…
    BioPharma Dive · 21d agoNeutral↗ source