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  • 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 · 3d agoRegulatoryNegative↗ source
  • Alzheon seeks up to $500M in new financing after Phase 3 setback for Alzheimer’s drug
    Alzheon, a biotech based in Framingham, Massachusetts, has been pursuing an Alzheimer’s therapy for more than a decade. Its lead candidate recently failed to achieve the primary goals in a Phase 3…
    Endpoints · 3d agoDealNeutral↗ source
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Infectious Disease464
  • FDA grants three-month review extension for Exelixis' metastatic colorectal cancer candidate
    Exelixis, a California drug developer, has provided the FDA with additional safety and efficacy data for its experimental therapy aimed at treating metastatic colorectal cancer. The agency respond…
    Endpoints · 3d agoRegulatoryNeutral↗ 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 · 4d agoDealNegative↗ source
  • FDA signals openness to innovative trial designs for psychedelic therapies
    FDA regulators said they are willing to consider more flexible approaches for evaluating psychedelic medicines. The agency noted that studies could use active comparators instead of placebo, which…
    Endpoints · 4d agoRegulatoryPositive↗ source
  • 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 · 4d 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 · 4d 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 · 3d 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 · 3d agoPositive↗ source
  • Shionogi's mid-stage stroke drug redasemtide fails, while Bayer's Hyrnuo receives expanded NSCLC label
    Shionogi reported that its experimental stroke therapy redasemtide did not achieve the primary endpoint in a mid-stage clinical trial, marking a setback for the company’s neurology pipeline. The f…
    Endpoints · 4d agoNegative readoutNeutral↗ source
  • ARPA-H launches ADVOCATE program to fund AI agents for health tech companies
    ARPA-H, the federal agency that funds breakthrough health technologies, announced the start of a new initiative called ADVOCATE. The program will award millions of dollars in grants to health-tech…
    Endpoints · 4d agoPositive↗ source
  • FDA imposes partial clinical hold on Biohaven's experimental epilepsy drug BHV-7000
    FDA announced a partial clinical hold on Biohaven's ion channel program, affecting the epilepsy trial of the experimental drug BHV-7000. The hold was issued after the agency requested additional p…
    Endpoints · 4d agoRegulatoryNegative↗ source
  • BridgeBio Oncology shares tumble 24% as it narrows KRAS program focus
    BridgeBio Oncology Therapeutics saw its stock drop sharply after announcing a strategic shift. The company said it will scale back its broader pipeline to concentrate resources on its lead KRAS in…
    Endpoints · 4d agoNegative↗ 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 · 4d 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 · 4d agoPositive↗ source
  • Pharma investment in UK rises as government increases drug pricing and engagement
    The UK trade group says pharmaceutical investment is picking up after a lull last year. The uptick follows recent government steps to raise reimbursement rates for medicines and to foster closer c…
    Endpoints · 4d agoRegulatoryPositive↗ source
  • Lonza announces new spray-drying plant in Bend, Oregon as Samsung Bio secures $262 million contract
    Lonza announced plans to construct a new commercial spray-drying facility in Bend, Oregon, expanding its manufacturing footprint in the United States. The plant will increase Lonza’s capacity to p…
    Endpoints · 4d agoPositive↗ 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 · 3d agoNegative↗ source
  • Biotech industry rebounds as Endpoints 11 awards return in Boston
    The article notes that the Endpoints 11 awards will be unveiled in Boston on the night of September 24, marking the event’s return after a period of industry slowdown. It reflects on how the biote…
    Endpoints · 4d agoNeutral↗ 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 · 4d agoNeutral↗ source
  • Oura files S-1, outlining its plans to expand into healthcare as it prepares for IPO
    Oura, known for its sleep-tracking ring, has submitted a registration statement on Form S-1 as it moves toward an initial public offering. In the filing, the company describes a broader healthcare…
    Endpoints · 4d agoRegulatoryNeutral↗ 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 · 5d 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 · 5d 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 · 5d 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 · 5d agoNegative readoutNegative↗ source