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20 stories matching this filter · ← front page

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STAT954Endpoints729BioPharma Dive280BioSpace177Fierce Biotech167onclive165globenewswire health73raps
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allOncology5558Rare Disease1213Cardiology1039Hematology916Immunology907Vaccines792Pulmonology
  • Otsuka's Voyxact hits key secondary endpoint in Phase 3 IgA nephropathy trial as BioNTech cuts revenue outlook
    Otsuka announced that its experimental kidney drug Voyxact met a key secondary endpoint in the Phase 3 VISIONARY study of patients with IgA nephropathy. The positive result suggests the therapy ha…
    Endpoints · 9d agoPositive readoutNeutral↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 21d agoRegulatoryPositive↗ source
59
fda recalls39
fda medwatch28
fda press24
760
Psychiatry & CNS677
Ophthalmology338
Endocrinology & Metabolism335
Pain328
Infectious Disease320
  • Dimerix acquires Mission’s acute kidney injury candidate for $5 million upfront
    Dimerix announced it has signed a deal to acquire a kidney injury drug candidate from Mission Therapeutics. The asset is ready to enter Phase 2 trials for the treatment of acute kidney injury. Und…
    Endpoints · 27d agoDealPositive↗ source
  • Nava Therapeutics emerges with $89M for lipid nanoparticles
    Nava Therapeutics, a secretive startup that’s been working on a new generation of lipid nanoparticles that target the bone marrow, immune cells and the kidney, has raised $89 million, the company t…
    Endpoints · 29d ago↗ source
  • Otsuka reports long-term kidney data key to Voyxact's bid for full approval
    Otsuka on Thursday reported new long-term data that it hopes will convert an accelerated approval to a full green light in kidney disease. The company said the Phase 3 study showed Voyxact stabiliz…
    Endpoints · 1mo ago↗ source
  • Ipsen to scoop up Memo Therapeutics and its kidney infection drug
    Ipsen is on an M&A roll. The French drugmaker announced its second deal of the week, saying it would buy Memo Therapeutics and its drug candidate called potravitug for a viral ...
    Endpoints · 1mo ago↗ source
  • Unicycive gets second CRL for kidney drug as manufacturing woes continue
    Unicycive Therapeutics’ chronic kidney disease drug was rejected by the FDA for a second time over persistent issues at a third-party contract manufacturer. The company’s phosphate binder drug oxyl…
    Endpoints · 1mo ago↗ source
  • Merck brings Welireg-Keytruda combo to treat kidney cancer
    Merck’s Welireg and Keytruda combination won approval as an adjuvant treatment for kidney cancer patients after surgery to remove all or part of the organ. The combination was approved Friday for ...
    Endpoints · 2mo ago↗ source
  • SonoThera raises $125M for non-viral gene therapy approach
    SonoThera has secured $125 million to take its ultrasound-based gene therapy technology into the clinic. The company is focused on two lead programs in Duchenne muscular dystrophy and autosomal dom…
    Endpoints · 2mo ago↗ source
  • Lilly strikes Ascidian deal worth up to $1.9B for RNA editing in kidney diseases
    Last month, Ascidian Therapeutics presented the first data suggesting a new way to fix broken genes may be safe in people. Now Eli Lilly has struck a deal with the startup. Ascidian’s ...
    Endpoints · 2mo ago↗ source
  • Travere pays Everest $112M upfront to grow rare kidney disease pipeline
    Travere Therapeutics is enlisting the help of China-based Everest Medicines to bolster its rare kidney disease pipeline beyond its approved medicine Filspari. The San Diego biotech is doling out $1…
    Endpoints · 2mo ago↗ source
  • Safety and Toxicity Management in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss practical approaches to monitoring and managing toxicities associated with radiopharmaceutical therapies in metastatic castration-resistant prostate…
    onclive · 3mo ago↗ source
  • Combination and Sequencing Strategies in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss ongoing questions surrounding combination approaches and optimal sequencing strategies for radiopharmaceutical therapies in metastatic castration-res…
    onclive · 3mo ago↗ source
  • GU Cancer Experts Highlight Top Abstracts to Watch During ASCO 2026
    We spoke with leading voices in GU oncology to see which presentations they are most looking forward to during the 2026 ASCO Annual Meeting.
    onclive · 3mo ago↗ source
  • Dr Silbermann on Clinical Trial Design Considerations in Multiple Myeloma
    Rebecca Silbermann, MD, MMS, outlines key trial design considerations in multiple myeloma, including supportive care measures and end point selection.
    onclive · 3mo ago↗ source
  • Renal Cell Carcinoma: Real-World Factors in First-Line Treatment Selection
    In this segment, Dr. Elizabeth Plimack and Dr. Yasser Ged discuss how real-world patient factors influence first-line treatment decisions in renal cell carcinoma.
    onclive · 3mo ago↗ source
  • Expanding ctDNA Applications to RCC and Germ Cell Tumors
    Experts explain how ctDNA tracking in metastatic cancer guides therapy tweaks, flags relapse early, and where it fails in brain/peritoneal disease.
    onclive · 3mo ago↗ source
  • Renal Cell Carcinoma: Practical Treatment Selection Across Risk Groups
    In this segment, Dr. Elizabeth Plimack leads a discussion with Dr. Sundhar Ramalingam and Dr. Yasser Ged on how clinicians approach treatment selection in renal cell carcinoma across different IMDC…
    onclive · 3mo ago↗ source
  • Clinical Scenario Presentation and Treatment Approach for Progressive Disease
    Experts weigh mutation testing, comorbidities, and patient preference to guide second-line CLL options after BTK inhibitor resistance.
    onclive · 3mo ago↗ source
  • Dr McGregor on Key End Points of the STRIKE Trial of Tivozanib Plus Pembrolizumab in RCC
    Bradley McGregor, MD, discusses the end points that will be evaluated in the phase 3 STRIKE trial of adjuvant tivozanib plus pembrolizumab in high-risk RCC.
    onclive · 3mo ago↗ source