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661 stories matching this filter · ← front page

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  • Revolution Medicines secures FDA approval for Rasonque, a RAS inhibitor targeting advanced pancreatic cancer
    Revolution Medicines announced FDA approval of its RAS inhibitor Rasonque for patients with advanced pancreatic cancer, marking a milestone for the company. The approval is seen as a breakthrough…
    Fierce Biotech · 1d agoApprovalPositive↗ 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 · 1d agoRegulatoryNegative↗ source
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fda recalls71
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Infectious Disease457
  • FDA plans study on barriers to women's enrollment in pregnancy exposure registries and announces PRV fee rates
    The Food and Drug Administration said it will conduct research into perceived barriers that limit women’s participation in pregnancy exposure registries. It also released the fee schedule for prio…
    raps · 1d agoRegulatoryNeutral↗ source
  • Whole Foods recalls Cabricharme cheese after undisclosed egg protein found
    Whole Foods Market announced a recall of its Fromagerie Coop de Mean Cabricharme cheese after testing revealed the presence of egg lysozyme, an egg-white protein that was not listed on the label.…
    fda recalls · 19h agoRegulatoryNegative↗ source
  • Novartis shareholder urges board overhaul after costly Avidity acquisition setbacks
    Novartis investor David Samra, managing director at Artisan Partners, told Reuters that the company’s board should be reshaped to improve oversight of its dealmaking activities. He said the board n…
    Fierce Biotech · 2d agoDealNegative↗ 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 · 2d agoDealPositive↗ source
  • 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 · 1d 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 · 1d 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 1d 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 · 2d 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 · 2d 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 · 1d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d agoPositive readoutPositive↗ 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 · 3d 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 · 3d 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 · 3d agoDealPositive↗ source