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  • Entrada's Duchenne drug shows disappointing early data, shares tumble
    Entrada disclosed initial results from a low‑dose version of its exon‑44 skipping therapy for Duchenne muscular dystrophy. The data, collected from six patients, failed to meet the company’s expect…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Amgen invests $300 million in Puerto Rico biologics plant as Novartis plans to close German oral drug factory
    Amgen announced an additional $300 million investment in Puerto Rico to expand its biologics manufacturing capacity in Juncos, building on earlier commitments. The funding will be used to upgrade…
    Endpoints · 4mo agoDealNeutral↗ source
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  • Sanofi asks FDA to withdraw teplizumab from fast-track review after internal disagreement
    Sanofi has formally requested that the U.S. Food and Drug Administration remove its type 1 diabetes therapy, teplizumab, from the agency's new speedy review program. The request follows a disagree…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Atara and Pierre Fabre's T-cell therapy gets new chance for FDA approval after twice rejected
    Atara Biotherapeutics and Pierre Fabre Pharmaceuticals have received notice from the U.S. FDA that it will reconsider a previously rejected T-cell therapy. The therapy, which had been turned down…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Clinicians map next-line EGFR lung cancer treatments using NGS, radiation, chemo, amivantamab and ADCs
    Clinicians treating non‑small cell lung cancer with EGFR mutations must adapt when tumors become resistant to first‑line therapies. The latest guidance highlights the use of next‑generation sequenc…
    onclive · 4mo agoNeutral↗ source
  • Experts discuss real-world evidence and research gaps in metastatic castration-sensitive prostate cancer
    Industry and academic experts gathered to examine how real-world evidence can be used to compare treatments for metastatic castration-sensitive prostate cancer. They highlighted the strengths and l…
    onclive · 4mo agoNeutral↗ source
  • Zanidatamab shows strong single-agent activity in HER2-positive gastric and biliary cancers
    Zanidatamab, a dual HER2-binding antibody, demonstrated notable efficacy as a single agent in studies of gastric and biliary tract cancers. The activity was described as striking, suggesting that…
    onclive · 4mo agoPositive readoutPositive↗ source
  • Entrada Therapeutics' next-gen Duchenne drug fails early trial, raising competitive concerns
    Entrada Therapeutics reported that its next-generation exon-skipping therapy for Duchenne muscular dystrophy did not meet efficacy endpoints in an early-stage study. The trial, which evaluated the…
    STAT · 4mo agoNegative readoutNegative↗ source
  • FDA staff cuts leave agency scrambling to rebuild workforce after 3,500 layoffs
    The Food and Drug Administration dismissed roughly 3,500 employees last year as part of a health‑policy push to reduce what officials called bureaucratic bloat. The mass layoffs have left the agenc…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Astellas reports promising early results for stem cell eye therapy ASP7317 in age-related disease
    Astellas announced data from an early-stage trial of ASP7317, a stem cell-derived therapy aimed at an age-related eye condition. The study showed encouraging signs of efficacy and safety in most p…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Experts preview promising triple-negative breast cancer studies for ASCO 2026
    At the 2026 ASCO Annual Meeting, leading breast cancer specialists highlighted the triple-negative breast cancer (TNBC) abstracts they consider most likely to influence clinical practice. The disc…
    onclive · 4mo agoNeutral↗ source
  • FDA reexamines previously rejected rare cancer therapy amid claims of political interference
    The FDA has opened a new review of a treatment for a rare form of cancer that it had turned down a few months earlier. The reconsideration arrives as the agency faces fresh allegations that politi…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Lung cancer abstracts set to shape discussions at ASCO 2026
    OncLive has compiled a preview of lung‑cancer presentations that leading oncologists expect to influence clinical talks at the 2026 ASCO Annual Meeting in Chicago. The preview highlights insights f…
    onclive · 4mo agoNeutral↗ source
  • Experts discuss PD-L1 testing for HER2-positive metastatic gastric cancer as new trial data shifts immunotherapy timing
    The HERIZON-GEA-01 trial outlines its design and geographic enrollment while focusing on PD-L1 testing in HER2-positive metastatic gastric cancer. Clinicians and researchers are debating the role…
    onclive · 4mo agoNeutral↗ source
  • STK11 and MTAP loss reshape NSCLC prognosis and immunotherapy response, prompting new dual-checkpoint and PRMT5 inhibitor trials
    Recent analyses highlight that loss of the STK11 gene and co‑deletion of MTAP are common in non‑small cell lung cancer and are linked to poorer overall prognosis. These genetic alterations also ap…
    onclive · 4mo agoNeutral↗ source
  • FDA agrees to revisit rare blood cancer drug Ebvallo after companies address concerns
    Two companies developing a therapy for a rare blood cancer have reached an agreement with the FDA to address the agency’s concerns about their drug Ebvallo. The FDA had previously rejected Ebvallo…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • AI-generated fake citations surge, study finds they are polluting scientific literature
    A new study published in The Lancet reports a sharp rise in fabricated citations that do not correspond to real papers, threatening the reliability of the scientific record. The researchers found…
    STAT · 4mo agoNegative↗ source
  • WHO briefs on hantavirus outbreak aboard cruise ship, Spain to allow docking in Canary Islands
    WHO held a press conference Thursday to update on a suspected hantavirus outbreak on the cruise ship MV Hondius. The vessel is expected to dock in Tenerife, Canary Islands, after Spain agreed to t…
    STAT · 4mo agoNeutral↗ source
  • Seaport Therapeutics goes public as obesity drug race heats up and FDA commissioner faces White House scrutiny
    Seaport Therapeutics announced a successful initial public offering, with CEO Daphne Zohar discussing the company’s next steps on the latest Readout LOUD podcast. The episode also highlighted the…
    STAT · 4mo agoNeutral↗ source
  • Health insurers grapple with profit cuts after a costly 2025, outlook for 2026 remains uncertain
    In 2025, a wave of health insurers reduced or withdrew their profit forecasts after being hit by rising medical expenses. The cost pressures stemmed from higher drug prices, increased utilization…
    Endpoints · 4mo agoNegative↗ source
  • Analyst doubts gold-based ALS therapy from Clene, calling it ineffective
    Adam Feuerstein, a senior biotech writer, published a piece in his Biotech Scorecard newsletter questioning a new ALS treatment. The company Clene is developing CNM-Au8, which it describes as a hi…
    STAT · 4mo agoNegative↗ source
  • Expert discusses uncertainties in melanoma adjuvant therapy sequencing
    Dr. Mario Sznol, a professor of clinical medical oncology at the University of Miami, highlighted the difficulty of deciding whether to give adjuvant treatment to melanoma patients given the curren…
    onclive · 4mo agoNeutral↗ source
  • Women with bladder cancer often experience diagnostic delays as symptoms are mistaken for urinary infections
    Women with bladder cancer are frequently diagnosed later because their early signs are often confused with common urinary tract infections. Doctors say this confusion leads many patients to receiv…
    onclive · 4mo agoNegative↗ source
  • Amazon Pharmacy adds Ozempic pill to its same-day prescription kiosks
    Amazon Pharmacy announced that its same-day prescription kiosks will now dispense the Ozempic tablet, expanding the range of drugs available through the vending-style machines. The kiosks, which h…
    Endpoints · 4mo agoNeutral↗ source
  • Study Finds Screening Gap for HTLV-1 Linked Leukemia in US Caribbean-Born Communities
    Researchers at Sylvester Comprehensive Cancer Center have highlighted a gap in screening for adult T‑cell leukemia/lymphoma (ATLL) that could be addressed by preventing mother‑to‑child transmission…
    onclive · 4mo agoPositive↗ source