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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
  • 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
  • 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
  • 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
  • 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
  • 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