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2,398 stories matching this filter · ← front page

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  • FDA approves small-molecule dasatinib formulation, expanding CML treatment options
    Dr Michael J. Mauro explained that the FDA gave its nod in November 2025 to a generic, small-molecule version of dasatinib, the drug sold as Sprycel, for adult patients with Philadelphia-positive c…
    onclive · 4mo agoApprovalPositive↗ source
  • Sarepta's Elevidys sales beat forecasts but dip again, prompting stock slide and shift to RNA pipeline
    Sarepta Therapeutics reported that its gene therapy Elevidys generated net product revenue that exceeded Wall Street estimates for the first quarter. However, sales continued to decline compared wi…
    BioPharma Dive · 4mo agoEarningsNegative↗ source
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  • Entrada Therapeutics shares plunge after Duchenne trial shows modest dystrophin increase
    Entrada Therapeutics reported early data from a Phase 1/2 study of its RNA‑based therapy ENTR‑601‑44 for Duchenne muscular dystrophy, noting favorable safety and tolerability. The trial showed a d…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • Political appointee stalls Sanofi drug approval, raising concerns about FDA interference
    STAT's D.C. Diagnosis newsletter reports that a political appointee is impeding the approval of a Sanofi drug, suggesting direct political interference at the FDA. The article notes that the appoi…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Daraxonrasib shows 35% response rate in second‑line RAS‑mutated pancreatic cancer
    Phase 1/2 data from a monotherapy study of daraxonrasib in patients with RAS G12‑mutated pancreatic ductal adenocarcinoma reported an objective response rate of 35% when used as a second‑line treat…
    onclive · 4mo agoPositive readoutPositive↗ source
  • FDA holds Type A meeting with Atara after CRL issued for tabelecleucel in EBV-positive PTLD
    The FDA and Atara Biotherapeutics met in a Type A meeting to discuss the complete response letter (CRL) that the agency issued for the biologics license application of tabelecleucel, a therapy for…
    onclive · 4mo agoCRLNegative↗ source
  • 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
  • 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
  • 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
  • Roche to acquire digital pathology firm PathAI in deal potentially worth over $1B
    Roche plans to offer PathAI’s tools as part of an effort to improve cancer diagnosis and tailored treatment.
    BioPharma Dive · 4mo agoDealNeutral↗ 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
  • 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
  • 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
  • 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
  • Experts discuss strengths and limits of real-world studies for prostate cancer drug comparisons
    Experts highlighted that observational and propensity-matched analyses are increasingly used to compare treatments for metastatic castration-sensitive prostate cancer. They noted that such real-wo…
    onclive · 4mo agoNeutral↗ source
  • Study finds researchers become less disruptive as they age, favoring incremental work
    A new study published in Science reports that scientists tend to produce their most disruptive work early in their careers, but shift toward less groundbreaking research as they get older. The ana…
    STAT · 4mo agoNeutral↗ source
  • CDC’s cruise ship health chief Luis Rodríguez retires amid hantavirus outbreak on MV Hondius
    The Centers for Disease Control and Prevention announced that Luis Rodríguez, who has been with the Vessel Sanitation Program since 2010 and its chief since 2023, will retire. His departure comes…
    STAT · 4mo agoNeutral↗ source