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2,124 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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  • EnGene shares tumble 80% after Phase 2 bladder cancer data raise safety concerns
    EnGene, a Canadian biotech firm, released updated Phase 2 results for its experimental therapy aimed at a specific group of bladder cancer patients. The company said the new data fell short of expe…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • 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
  • 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
  • Blackstone invests $250 million in Anagram to address cystic fibrosis complication
    Blackstone Life Sciences announced a $250 million investment in Anagram, a biotech focused on cystic fibrosis complications. The funding is part of one of the largest private investment funds in t…
    Endpoints · 4mo agoDealPositive↗ 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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