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32 stories matching this filter · ← front page

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  • Estuary debuts with $103M to develop kidney disease gene therapies
    Estuary Biotherapeutics raised the curtain on Friday with $103 million to support the advancement of two preclinical gene therapy candidates for the most common type of inherited kidney disease. Th…
    Endpoints · 3d ago↗ source
  • CSL agrees $355M upfront deal to co-develop Alentis anti-fibrosis drug for kidney and liver
    CSL, an Australian drugmaker, announced a partnership with Alentis Therapeutics that includes a $355 million upfront payment. Under the agreement, CSL will co-develop Alentis's anti-fibrosis candi…
    Endpoints · 15d agoDealNeutral↗ source
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FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
fda press · 21d agoApprovalPositive↗ source
  • Merck's Welireg receives FDA nod for expanded use with Lenvima in kidney cancer
    Merck announced that its drug Welireg has received FDA approval for use together with Eisai's Lenvima in patients with advanced renal cell carcinoma. The clearance broadens the indication, allowin…
    Endpoints · 24d agoApprovalPositive↗ source
  • Roche reports positive interim Phase 3 results for kidney drug, paving way for accelerated approval
    Roche announced interim results from its Phase 3 trial of a kidney disease therapy, indicating the study met its primary endpoints. The data, released on Wednesday, suggest the drug could qualify…
    Endpoints · 26d agoPositive readoutPositive↗ source
  • Vertex reports early kidney drug data, boosting hopes for broad label ahead of next year's pivotal readout
    Vertex Pharmaceuticals disclosed early data from its experimental kidney disease therapy inaxaplin, showing improvements on a urine-based biomarker. The drug demonstrated positive changes in two s…
    Endpoints · 27d agoPositive readoutPositive↗ source
  • Otsuka ICU Medical recalls one lot of 0.9% Sodium Chloride injection after possible potassium chloride mix-up
    Otsuka ICU Medical LLC announced a voluntary recall of a single lot of its 0.9% Sodium Chloride Injection, USP, 100 mL. The recall was triggered after a customer complaint revealed that the overwr…
    fda medwatch · 29d agoRegulatoryNegative↗ source
  • Vera Therapeutics reports two-year data showing Trutakna stabilizes kidney function in IgA nephropathy, paving way for full FDA approval
    Vera Therapeutics announced that its recently approved drug Trutakna has produced encouraging two-year results in patients with IgA nephropathy, a chronic autoimmune kidney disease. The data indic…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • 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 · 2mo 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 · 2mo agoRegulatoryPositive↗ source
  • 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 · 3mo agoDealPositive↗ source
  • Nava Therapeutics raises $89 million to advance lipid nanoparticle platform targeting bone marrow, immune cells and kidney
    Nava Therapeutics, a stealth-mode biotech, announced it has secured $89 million in financing, according to a statement to Endpoints News. The capital will support development of a next generation…
    Endpoints · 3mo agoDealPositive↗ source
  • Vera Therapeutics receives accelerated approval for Trutakna to treat IgA nephropathy
    Vera Therapeutics announced that its fusion protein atacicept, branded as Trutakna, has been granted accelerated approval by the FDA for the treatment of immunoglobulin A nephropathy, a chronic aut…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Otsuka presents long-term Phase 3 data for Voyxact, aiming to secure full FDA approval for kidney disease
    Otsuka announced new long-term results from the Phase 3 trial of its kidney disease drug Voyxact. The data show that the therapy stabilized kidney function over an extended period, building on ear…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Ipsen to acquire Memo Therapeutics and its kidney infection candidate
    French drugmaker Ipsen announced a new acquisition, agreeing to buy Memo Therapeutics along with its experimental kidney infection drug. This marks Ipsen's second transaction announced within a wee…
    Endpoints · 3mo agoDealPositive↗ source
  • Unicycive Therapeutics receives second FDA complete response letter for kidney drug amid manufacturing problems
    Unicycive Therapeutics' chronic kidney disease drug, a phosphate binder called oxylanthanum carbonate (OLC), has been rejected by the U.S. Food and Drug Administration for a second time. The FDA c…
    Endpoints · 3mo agoCRLNegative↗ source
  • Merck's Welireg and Keytruda combo receives FDA approval for adjuvant kidney cancer therapy
    Merck announced that its combination of the oral VEGFR inhibitor Welireg and the immunotherapy Keytruda has been cleared by the U.S. Food and Drug Administration. The clearance applies to patients…
    Endpoints · 4mo agoApprovalPositive↗ source
  • SonoThera secures $125 million to advance ultrasound-based gene therapy for Duchenne and polycystic kidney disease
    SonoThera announced it has raised $125 million in financing to move its ultrasound-based non-viral gene therapy platform toward clinical testing. The funding will support the company’s two lead pr…
    Endpoints · 4mo agoDealPositive↗ source
  • Otsuka presents new data to bolster full approval bid for Voyxact in IgA nephropathy
    Otsuka Pharmaceutical announced that new clinical evidence has been generated for its monoclonal antibody Voyxact, aimed at treating IgA nephropathy, a chronic autoimmune kidney disease. The data,…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Eli Lilly signs up to $1.9B deal with Ascidian Therapeutics for RNA editing in kidney disease
    Ascidian Therapeutics recently presented early data indicating that its novel RNA‑editing approach to repair faulty genes appears safe in humans, focusing on kidney disease applications. Eli Lilly…
    Endpoints · 4mo agoDealPositive↗ source
  • Travere Therapeutics pays $112 million upfront to China’s Everest Medicines to expand rare kidney disease pipeline
    Travere Therapeutics, a San Diego‑based biotech, announced a partnership with China‑based Everest Medicines to strengthen its rare kidney disease portfolio beyond its approved drug Filspari. Under…
    Endpoints · 4mo agoDealPositive↗ source
  • Dr Croll reviews study linking tumor size changes on scans to pathological outcomes after neoadjuvant therapy in kidney cancer
    Dr Benjamin Croll, MD, presented findings from a recent investigation into the relationship between radiographic size changes and pathological response in renal cell carcinoma patients receiving ne…
    onclive · 5mo agoNeutral↗ 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 · 5mo agoNeutral↗ source
  • Experts outline safety strategies for radiopharmaceutical treatment of advanced prostate cancer
    Dr. Johann De Bono and Dr. Pedro Barata presented a discussion focused on practical methods for monitoring and managing toxicities that arise from radiopharmaceutical therapies used in metastatic c…
    onclive · 5mo agoNeutral↗ source
  • GU oncology experts preview top abstracts slated for ASCO 2026
    The 2026 ASCO Annual Meeting will run from May 29 to June 2 in Chicago, featuring a dedicated genitourinary (GU) oncology program. Leading clinicians were asked what upcoming abstracts they conside…
    onclive · 5mo agoNeutral↗ source