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  • 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 · 6mo agoRegulatoryNegative↗ source
  • Angelini Pharma to Acquire Catalyst Pharmaceuticals for $4.1 B, Expanding U.S. Rare-Disease Portfolio
    Angelini Pharma announced Thursday it will purchase Catalyst Pharmaceuticals, a Florida‑based company focused on rare‑disease medicines, for about $4.1 billion in cash. The transaction values Cata…
    STAT · 6mo agoDealPositive↗ source
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  • 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoRegulatoryNegative↗ 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoNeutral↗ 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoNeutral↗ source
  • Hospital shootings have risen steadily since 2000, according to new data
    A new analysis shows that incidents of gunfire inside U.S. hospitals have been climbing each year since 2000. The report notes a clear upward trend in the frequency of these events, raising concer…
    STAT · 6mo agoNeutral↗ source