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70 stories matching this filter · ← front page

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  • FDA approves Hibsago, first antisense therapy for chronic hepatitis B
    The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without…
    fda press · 3h agoApprovalPositive↗ source
  • AstraZeneca partners with Oracle to boost clinical trial patient recruitment using AI
    AstraZeneca announced a collaboration with data-technology firm Oracle to apply artificial-intelligence tools to clinical-trial recruitment. The non-binding agreement will let the partners explore…
    Fierce Biotech · 20h agoDealPositive↗ source
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fda medwatch93
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fda press54
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Psychiatry & CNS1106
Ophthalmology844
Endocrinology & Metabolism686
Pain654
Nephrology634
  • Ambrose Healthcare acquires AM-Pharma for up to €161 million
    Ambrose Healthcare, a British rare‑disease specialist, announced it has completed the acquisition of Dutch biotech AM‑Pharma. The deal values the company at up to 161 million euros (about $181 mill…
    Fierce Biotech · 4d agoDealNeutral↗ source
  • City Therapeutics completes $200 million IPO, earmarks funds for RNAi therapies
    City Therapeutics, based in Cambridge, Massachusetts, launched an IPO raising $200 million, exceeding its original target of 9.7 million shares at $17-$19 per share. The company sold 11.1 million…
    Fierce Biotech · 4d agoDealPositive↗ source
  • 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 · 4d ago↗ source
  • Estuary Biotherapeutics raises $103M to advance gene therapies for polycystic kidney disease
    Estuary Biotherapeutics announced it has exited stealth mode after securing $103 million in financing to move two gene‑therapy candidates into clinical testing for autosomal dominant polycystic kid…
    Fierce Biotech · 5d agoDealPositive↗ source
  • IQVIA urges early clinical insight in drug discovery to boost patient benefit
    IQVIA Laboratories' leaders argue that drug discovery and clinical development should be linked early to improve patient outcomes. They explain that decisions made during discovery affect later cl…
    Fierce Biotech · 5d agoPositive↗ source
  • CSL pays $355M upfront to co-develop Alentis’ phase-2 fibrosis drug lixudebart
    CSL of Australia has agreed to pay $355 million upfront for the rights to Alentis Therapeutics' anti-Claudin-1 drug lixudebart, a phase-2 fibrosis candidate. The agreement includes up to $1.2 bill…
    Fierce Biotech · 15d agoDealPositive↗ 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
  • 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 · 22d agoApprovalPositive↗ source
  • Genentech CEO Ashley Magargee reflects on biotech origins and future amid growing startup ecosystem
    Genentech’s founder story was revisited in a recent interview with CEO Ashley Magargee. She recalled how co‑founder Herbert Boyer was initially skeptical of a brief meeting with venture capitalist…
    Fierce Biotech · 22d agoPositive↗ 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 · 25d agoApprovalPositive↗ source
  • Adicet Bio's off-the-shelf CAR-T therapy shows lupus remission in early Phase 1 trial
    Adicet Bio reported that its off-the-shelf CAR-T product prula-cel induced remission in more than half of lupus patients enrolled in a small Phase 1 study. One year after a single infusion, 12 of…
    Fierce Biotech · 25d agoPositive readoutPositive↗ source
  • ADARx upsizes Nasdaq IPO to $446M as City Therapeutics eyes public listing
    ADARx Pharmaceuticals, a San Diego-based RNA biotech, completed a Nasdaq initial public offering this morning, selling 26.3 million shares at $17 each. The offering generated gross proceeds of abo…
    Fierce Biotech · 25d agoDealPositive↗ source
  • NIH deputy director Nicole Kleinstreuer leads push to cut animal testing with new policies
    NIH has spent the past 18 months accelerating policies aimed at reducing the use of animals in research. The effort is being directed by Dr. Nicole Kleinstreuer, the agency’s deputy director for p…
    Fierce Biotech · 25d agoRegulatoryPositive↗ source
  • Roche signs $2 billion deal with Atavistik to discover allosteric cardiovascular-renal-metabolic drugs
    Roche announced a partnership with Cambridge-based biotech Atavistik Bio to develop allosteric small-molecule therapies for cardiovascular, renal and metabolic diseases. The agreement includes an u…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Travere appoints former Amicus CEO Bradley Campbell as new chief executive
    Travere Therapeutics CEO Eric Dube is stepping down after overseeing the launch of the rare kidney disease drug Filspari. Bradley Campbell will assume the role on Dec 1, bringing experience from l…
    Fierce Biotech · 26d agoNeutral↗ source
  • Roche reports phase 3 success for sefaxersen in IgA nephropathy, eyes accelerated approval
    Roche announced that its experimental drug sefaxersen met the primary endpoint in a phase 3 trial for IgA nephropathy, showing reduced proteinuria versus placebo. The interim analysis at week 37 d…
    Fierce Biotech · 27d agoPositive readoutPositive↗ 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 · 27d agoPositive readoutPositive↗ source
  • Vertex reports positive Phase 2b results for inaxaplin in APOL1-mediated kidney disease
    Vertex Pharmaceuticals announced positive Phase 2b data for its kidney disease candidate inaxaplin, which targets APOL1-mediated kidney disease (AMKD). The Amplified trial enrolled two cohorts: 2…
    Fierce Biotech · 28d 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 · 28d agoPositive readoutPositive↗ source
  • Novo Nordisk acquires three early-stage obesity programs from Kallyope
    Novo Nordisk announced the purchase of three early-stage obesity drug programs from New York‑based biotech Kallyope, expanding its metabolic pipeline. The acquired assets are not GLP‑1 incretins.…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Chutes & Ladders—Legend poaches Novartis vet to boost commercial potential
    After former Legend Biotech CEO Ying Huang, Ph.D., left the company suddenly in July, Legend has found its permanent CEO, poaching Novartis veteran Ingrid Zhang as the CAR-T specialist eyes its nex…
    Fierce Biotech · 1mo agoNeutral↗ 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
  • FDA pushes back decision on Exelixis' zanzalintinib and Roche's Tecentriq combo for metastatic colorectal cancer
    The FDA announced a delay in its decision on the approval of Exelixis' oral kinase inhibitor zanzalintinib when used with Roche's Tecentriq for metastatic colorectal cancer. The agency said it nee…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source