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2,386 stories matching this filter · ← front page

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  • FDA grants accelerated approval to sonrotoclax for relapsed/refractory mantle cell lymphoma
    The U.S. Food and Drug Administration has granted accelerated approval to sonrotoclax (brand name Beqalzi) for adult patients with relapsed or refractory mantle cell lymphoma who have received at l…
    onclive · 3mo agoApprovalPositive↗ source
  • FDA leadership gap deepens uncertainty for biotech as acting officials take charge
    Marty Makary's resignation as FDA commissioner has left the agency without a permanent head. Kyle Diamantas is serving as the temporary leader, while three senior drug-review positions are filled b…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
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fda recalls70
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Infectious Disease444
  • Lilly data show lower-dose GLP-1 injections and oral pill help sustain weight loss
    Eli Lilly presented new research on how patients who have lost weight with GLP‑1 medicines can maintain that loss over time. The studies followed people who had achieved significant reductions usin…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Assertio rejects Garda bid, accepts Zydus offer valuing company at $23.50 per share
    Assertio Holdings announced it has terminated its pending acquisition by Garda Therapeutics after the board approved a higher offer from another suitor. The new proposal from Zydus Worldwide value…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Pirtobrutinib Extends Progression-Free Survival to 14 Months in BTK-Inhibitor-Pretreated CLL Patients
    The phase 3 CLL-321 trial enrolled patients whose disease had progressed after prior covalent BTK inhibitor therapy. Participants were randomly assigned to receive pirtobrutinib or the investigator…
    onclive · 3mo agoPositive readoutPositive↗ source
  • FDA expands pirtobrutinib use to second-line CLL after covalent BTKi failure, broadening treatment options
    The BRUIN CLL-321 phase 3 trial provided the data that led the FDA to approve pirtobrutinib for patients whose chronic lymphocytic leukemia has progressed after a covalent BTK inhibitor. This marks…
    onclive · 3mo agoApprovalPositive↗ source
  • Oral SERDs show promise in hormone-receptor positive breast cancer, offering alternative to injections
    Oral selective estrogen receptor degraders (SERDs) are being positioned as a new approach for metastatic hormone-receptor positive breast cancer because they can break down the estrogen receptor an…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Retifanlimab plus chemo improves progression-free survival in first-line SCAC trial
    Topline results from the PODIUM-303 study show that adding the PD-1 inhibitor retifanlimab to carboplatin and paclitaxel improves outcomes for patients with squamous cell carcinoma of the anal cana…
    onclive · 3mo agoPositive readoutPositive↗ source
  • MD Anderson expert highlights impact of WHO’s updated AML diagnostic criteria on patient care
    Dr Sanam Loghavi, an associate professor and medical director at MD Anderson Cancer Center, discussed the recently revised WHO diagnostic criteria for acute myeloid leukemia. She emphasized that a…
    onclive · 3mo agoPositive↗ source
  • Tirabrutinib and CAR T-cell therapy show promise for relapsed/refractory primary CNS lymphoma
    Experts highlighted emerging data on tirabrutinib and CAR T-cell therapy as potential new options for patients with relapsed or refractory primary central nervous system lymphoma. CAR T-cell thera…
    onclive · 3mo agoRegulatoryPositive↗ source
  • Trump administration seeks new FDA commissioner to restore trust, prioritize food policy and accelerate drug approvals
    The Trump administration is moving quickly to name a successor to FDA commissioner Marty Makary, who resigned. Officials say the search will take several weeks and they are looking for a leader wh…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Experts discuss combination and sequencing approaches for radiopharmaceuticals in advanced prostate cancer
    Dr. Pedro Barata and Dr. Johann De Bono review the current questions surrounding how best to combine and sequence radiopharmaceutical therapies for patients with metastatic castration‑resistant pro…
    onclive · 3mo agoNeutral↗ source
  • U.S. overdose deaths drop 14% in 2025, marking third consecutive yearly decline
    Preliminary CDC data show about 70,000 overdose deaths in 2025, roughly 14% fewer than in 2024 and similar to 2019 levels before the pandemic. The decline was observed across major drug categories…
    STAT · 3mo agoPositive↗ source
  • Gene therapy viral vectors implicated in a child’s tumor, raising safety concerns
    A recent STAT+ report highlights a case where viral vectors used in gene therapy were found to be associated with a tumor in a young boy. The article notes that investigators have identified a poss…
    STAT · 3mo agoNegative↗ source
  • UCSF receives $100 million gift to fund capital projects, cancer research and hospital modernization
    Longtime supporters Kathy Chiao and Kenneth Hao have pledged $100 million to the University of California, San Francisco. The commitment is intended to address the university’s most urgent capital…
    onclive · 3mo agoDealPositive↗ source
  • Biomarker testing guides endometrial cancer treatment and highlights gaps in second-line options after immunotherapy
    The discussion highlighted that performing biomarker testing at diagnosis is now standard for endometrial cancer, helping decide between targeted therapies and immunotherapy. The experts described…
    onclive · 3mo agoNeutral↗ source
  • Podcast Highlights Community Oncology’s Growing Role in U.S. Cancer Care
    A new sponsored podcast episode explores how community oncology clinics are becoming a vital part of the U.S. cancer‑care landscape. The program, released in May 2026, discusses why these local cen…
    BioPharma Dive · 3mo agoPositive↗ source
  • Safety-boosting drug may weaken gene therapy efficacy in Dravet syndrome trial
    Encoded Therapeutics studied a drug meant to improve the safety of gene therapy in children with Dravet syndrome, a severe genetic epilepsy. In the trial of 21 participants, most received steroids…
    STAT · 3mo agoNegative readoutNegative↗ source
  • Doctors link infant's brain tumor to gene therapy virus in rare case
    Doctors treated 13-month-old Adam with an experimental gene therapy after his stem cell transplant failed, and the boy subsequently reached developmental milestones such as learning sign language a…
    STAT · 3mo agoNeutral↗ source
  • Alpha-emitting radiopharmaceuticals gain attention in metastatic castration-resistant prostate cancer
    Dr. Johann De Bono and Dr. Pedro Barata reviewed the current landscape of alpha-emitting radiopharmaceuticals for patients with metastatic castration-resistant prostate cancer (mCRPC). They highli…
    onclive · 3mo agoPositive readoutPositive↗ source
  • DOJ subpoenas signal start of criminal probe into gender-affirming care for minors
    Several hospitals have been served with grand jury subpoenas that request information about gender‑affirming treatments provided to minors, indicating that the Justice Department has opened a crimi…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • FDA Commissioner Marty Makary resigns, Kyle Diamantas named acting commissioner
    The U.S. Food and Drug Administration announced that Commissioner Marty Makary will step down from his position. The agency said that Kyle Diamantas, who currently oversees food regulation, will se…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Lack of Affordable Air Conditioning Poses Fatal Risk for Diabetes Patients, Experts Warn
    The opinion piece by Charles Leonard and Anthony Nicome argues that access to air conditioning should be treated as essential preventive care for people with chronic illnesses, especially diabetes,…
    STAT · 3mo agoNegative↗ source
  • Trump admin defers $1.3 billion in Medicaid payments to California over fraud concerns
    Vice President JD Vance announced that the federal government will hold back $1.3 billion in Medicaid reimbursements to California while investigations into alleged fraud continue. The move is part…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Hantavirus outbreak on cruise ship tests US biocontainment capacity, highlights response gaps
    Passengers from the MV Hondius cruise ship were placed in a Nebraska quarantine facility after several were diagnosed with Andes hantavirus, an emerging infectious disease. The virus, while deadly…
    STAT · 3mo agoNeutral↗ source