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1,269 stories matching this filter · ← front page

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  • Molecular residual disease testing offers earlier insight into cancer treatment response
    In oncology, determining whether cancer has truly been eliminated after therapy is challenging because imaging and standard clinical criteria often miss low‑level disease. Molecular residual diseas…
    Fierce Biotech · 2mo agoPositive↗ source
  • Frazier Life Sciences raises over $1.1 billion for its public biotech fund, now $2.8 billion total
    Frazier Life Sciences announced that its public fund has secured more than $1.1 billion in new capital, bringing the fund’s total assets to $2.8 billion. The fund, launched in 2021, targets small-…
    Fierce Biotech · 2mo agoDealPositive↗ source
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Nephrology759
  • New FDA Oncology Center chief Angelo de Claro pledges AI integration and trial expansion
    Angelo de Claro, M.D., has taken over as the permanent head of the FDA’s Oncology Center of Excellence after serving as acting director since late 2025. In his first interview, he said the agency w…
    Fierce Biotech · 2mo agoRegulatoryNeutral↗ source
  • Singapore opens biotech-focused Boston hub, strengthening ties with city
    Singapore announced the opening of its fifth U.S. overseas centre, a biotech-focused hub in Boston, during an event at the historic Raffles Hotel. Government officials and business leaders gathered…
    Fierce Biotech · 2mo agoPositive↗ source
  • FDA places partial hold on Biohaven epilepsy drug BHV-7000 amid $350 million licensing deal
    The U.S. Food and Drug Administration issued a partial clinical hold on enrollment for Biohaven’s epilepsy candidate BHV-7000 after rodent studies raised questions about drug metabolites. The hold…
    Fierce Biotech · 2mo agoRegulatoryNegative↗ source
  • Takeda R&D chief Andy Plump to retire after string of recent FDA approvals
    Takeda's long-serving research and development president Andy Plump will step down in June. He joined the Japanese drugmaker in 2015 from Sanofi and has led the R&D organization since then. His ex…
    Fierce Biotech · 2mo agoPositive↗ source
  • UK issues AI-in-medicine regulatory recommendations; FDA pauses new enrollment in Biohaven epilepsy trials
    The United Kingdom has released a set of recommendations aimed at governing the use of artificial intelligence in medical applications. The guidance outlines how AI tools should be evaluated and mo…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA signals openness to innovative approaches for psychedelic drug development
    FDA officials said the agency is open to novel, innovative approaches to the clinical development of psychedelic drugs, citing the worsening mental health crisis in the United States. The agency’s…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Scientists boycott American Diabetes Association after conference expulsions
    Following the removal of five scientists from its annual conference in June, members of the American Diabetes Association (ADA) have initiated a boycott of the organization. The protest stems from…
    Fierce Biotech · 2mo agoNegative↗ source
  • EMA revises GVP inspection guideline to incorporate new subcontractor rules
    The European Medicines Agency has issued an update to its guideline on good pharmacovigilance practice inspections. The revision aligns the guidance with recent changes to the rules governing subco…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Takeda R&D chief Andy Plump to leave after 12 years
    Takeda announced that its President of Research and Development, Andy Plump, M.D., Ph.D., will depart the company in June after serving in the role for twelve years. He will remain in charge of R&D…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Evergreen Fresh Sprouts recalls 215 cases of broccoli sprouts over possible Salmonella contamination
    Evergreen Fresh Sprouts LLC of Moyie Springs, Idaho announced a recall of 215 cases of its broccoli sprouts due to potential Salmonella contamination. The product, packaged in 4‑oz zip‑lock bags,…
    fda recalls · 2mo agoRegulatoryNegative↗ source
  • Evommune gives up hope for MRGPRX2 antagonist to treat itch after latest phase 2 fail
    Evommune’s MRGPRX2 antagonist has flunked another phase 2 trial, wiping out the biotech’s last hopes of developing the therapy for any itch-related conditions.
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • Luma Group closes $410 million, 15-year life-science venture fund
    Luma Group announced that its first life‑science venture capital fund has reached final close, raising $410 million for a 15‑year investment period. The New York‑based firm said the capital will be…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Encoded Therapeutics secures $275M Series F to push Dravet gene therapy and expand manufacturing
    Encoded Therapeutics, a biotech focused on neuro‑genetic disorders, announced a $275 million Series F financing round. The capital was co‑led by Google Ventures and an undisclosed healthcare fund,…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Tyra Biosciences reports phase 2 bladder cancer data, complete response rates miss analyst targets, shares slide
    Tyra Biosciences disclosed early phase 2 results for its FGFR3‑selective inhibitor dabogratinib in patients with low‑grade, intermediate‑risk non‑muscle‑invasive bladder cancer. The trial evaluate…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • Abbott receives FDA clearance for TactiFlex Duo catheter, offering flexible AFib ablation options
    Abbott announced that the U.S. Food and Drug Administration has cleared its new TactiFlex Duo catheter for use in atrial fibrillation ablation. The catheter can deliver pulsed field ablation, radi…
    Fierce Biotech · 2mo agoRegulatoryPositive↗ source
  • Beeline's oral lupus drug afimetoran meets primary endpoint in Phase 2, paving way for Phase 3
    Beeline Medicines announced that its oral small-molecule inhibitor afimetoran achieved the primary endpoint in a 48-week Phase 2 trial in patients with systemic lupus erythematosus (SLE). The tria…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • Gilead says its oncology and inflammation portfolio has reached critical mass after series of acquisitions
    Gilead Sciences CEO Daniel O’Day told Fierce that the company’s push into oncology and inflammation has now reached a point of critical mass, with a pipeline that spans early research to late‑stage…
    Fierce Biotech · 2mo agoPositive↗ source
  • nPhase unveils AI-driven clinical data platform to accelerate trial design and submission
    nPhase, a clinical research organization, announced the launch of an end-to-end platform called nPhase.ai that uses artificial intelligence to manage clinical trial data. The platform includes a S…
    Fierce Biotech · 2mo agoPositive↗ source
  • Kura Oncology launches Caspian Therapeutics with $50M funding to develop next-generation diabetes drug
    Kura Oncology has created a new biotech called Caspian Therapeutics and secured $50 million in financing to advance a next-generation diabetes treatment. The spinout will focus on KO-7246, a highl…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Labcorp acquires MLM Medical Labs to expand global lab network across four continents
    Labcorp, a major medtech and testing company, announced it has completed the acquisition of MLM Medical Labs. MLM operates central and specialty labs in the United States, Germany, and South Afric…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Solstice Oncology raises $225M Series A to push next-gen CTLA-4 antibody into Phase 2 colon cancer trial
    Solstice Oncology announced a $225 million Series A financing led by RA Capital Management, with participation from Canaan Partners and Forbion. The capital will fund the Phase 2 study of its Fc-e…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • FDA appoints permanent heads of drug, biologics and tobacco centers and adds AI deputy commissioner
    The U.S. Food and Drug Administration announced permanent appointments for the leaders of its major product centers. The Center for Drug Evaluation and Research and the Center for Biologics Evalua…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Massachusetts governor warns early-stage biotech firms of capital crunch ahead of election
    Massachusetts Governor Maura Healey visited the MassBio headquarters in Cambridge, meeting with roughly 50 CEOs of early-stage biotech companies. The gathering, held on a Wednesday afternoon, was i…
    Fierce Biotech · 2mo agoNegative↗ source