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  • Tyra Biosciences reports Phase 2 success in low-risk bladder cancer, plans pivotal trial
    Tyra Biosciences announced that its experimental therapy for low‑risk bladder cancer has produced encouraging results in a Phase 2 study. The company said the data, released on Wednesday, represen…
    Endpoints · 2mo agoPositive readoutPositive↗ 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
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  • 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
  • ARPA-H selects UpDoc, Tempus AI and Atman Health for new AI heart-disease program
    ARPA-H announced a new initiative called ADVOCATE that will bring together three companies to develop AI-driven tools for managing heart disease. The selected firms - UpDoc, Tempus AI, and Atman H…
    Endpoints · 2mo agoPositive↗ source
  • Beeline Medicines reports promising Phase 2 lupus data
    Beeline Medicines, a Bain‑backed startup, announced encouraging mid‑stage results for its lupus candidate afimetoran, a drug originally sourced from Bristol Myers Squibb. The Phase 2 trial data we…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Advancing New Approach Methodologies: Building Standards and Evidence to Boost Preclinical Adoption
    New Approach Methodologies (NAMs) are being hailed as a way to transform preclinical research and toxicology, but their wider use has been hampered by three key barriers: sourcing appropriate cells…
    Fierce Biotech · 2mo agoPositive↗ source
  • FDA appoints permanent heads for CDER and CBER amid pending commissioner confirmation
    The Department of Health and Human Services announced that Michael Davis, MD, PhD, and Karim Mikhail will become the permanent directors of the Centers for Drugs Evaluation and Research and the Cen…
    Fierce Biotech · 2mo agoRegulatoryNeutral↗ source
  • Researchers urge FDA to adopt EMA-style drug rejection letter disclosures
    The FDA began publishing letters that explain why a drug application was denied in September 2025, marking a significant transparency shift. Researchers argue that the agency’s current disclosures…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • NodThera rebrands as Rezera and targets Phase 3 trial in 2027
    NodThera, a biotech focused on the NLRP3 inflammatory pathway for about ten years, announced a strategic shift. The company said it will rebrand itself as Rezera and is preparing to launch a pivot…
    Endpoints · 2mo agoNeutral↗ source
  • Evommune's MRGPRX2 antagonist fails second Phase 2b trial in atopic dermatitis
    Evommune reported that its experimental small-molecule antagonist of the MRGPRX2 receptor did not meet its primary endpoints in a Phase 2b study in patients with atopic dermatitis. The study, cond…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • FDA grants accelerated approval to AstraZeneca’s Etcamah, enabling ctDNA-guided therapy for HR-positive breast cancer
    The FDA issued an accelerated approval for AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be sold as Etcamah, marking a rare departure from its advisory committee’s recomm…
    Fierce Biotech · 2mo agoApprovalPositive↗ source
  • AstraZeneca’s IL-33 antibody tozorakimab earns FDA priority review after COPD trial cuts exacerbations by up to 34%
    AstraZeneca’s R&D chief medical officer Sharon Barr said the company’s latest data on its IL-33 inhibitor represents an internal “science success story.” The results have earned the drug a priority…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • Boston Scientific recalls spinal cord stimulator leads after over 1,000 serious injuries
    Boston Scientific announced a recall of its Infinion CX spinal cord stimulation leads after the FDA classified the action as the most serious level. The recall, issued June 17, covers all unused l…
    Fierce Biotech · 2mo agoCRLNegative↗ source
  • Amgen reports positive lung cancer trial results for Imdelltra combined with checkpoint inhibitor
    Amgen announced that its T-cell engager candidate Imdelltra, when used together with a checkpoint inhibitor, showed a clinical benefit in patients with advanced lung cancer. The trial data indicat…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • FDA finalizes Krazati withdrawal while Wegovy trial shows positive results in children 6-12
    Regulators have officially completed the withdrawal of Krazati, a drug that was being developed for second-line treatment of colorectal cancer. The FDA’s final action ends the product’s availabilit…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Roivant's inhaled drug mosliciguat achieves positive Phase 2 results in interstitial lung disease
    Roivant Sciences reported that its inhaled candidate mosliciguat has successfully completed a Phase 2 trial in patients with interstitial lung disease. The study met its primary endpoint, showing a…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Spyre Therapeutics reports positive Phase 2 results for anti-IL-23 antibody SPY003 in ulcerative colitis
    Spyre Therapeutics announced that its anti‑IL‑23 antibody, SPY003, achieved its primary and secondary goals in a Phase 2 ulcerative colitis study. The trial, part A of the Skyline program, enrolled…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • BMS CAR-T therapy arlo-cel meets primary endpoint in pivotal multiple myeloma trial
    Bristol Myers Squibb reported that its GPRC5D-directed CAR-T cell therapy, arlo-cel, achieved the primary endpoint in the pivotal Quintessential trial for multiple myeloma. The study enrolled pati…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • Pharvaris reports injectable-like efficacy from once-daily oral pill for rare genetic disease
    Pharvaris announced that its experimental oral formulation of deucrictibant achieved efficacy comparable to injectable versions in a once-daily pill. The drug is an extended-release version intend…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Sanofi presents detailed asthma trial data while AstraZeneca reports positive COPD results at ERS 2026
    At the European Respiratory Society meeting in Barcelona, Sanofi disclosed detailed findings from its asthma trial, building on earlier indications of efficacy. The data highlighted specific endpo…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Schrödinger launches Tectora Therapeutics with $55 million Series A to target immunology and inflammation
    Schrödinger announced the formation of Tectora Therapeutics, a new biotech focused on immune‑mediated diseases, backed by a $55 million Series A financing round. As part of the launch, Schrödinger…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Sandoz announces $300 million biosimilar factory in Slovenia and plans to expand pipeline sevenfold
    Sandoz, the generic and biosimilar division of Novartis, said it will invest $300 million to build a new biosimilar manufacturing facility in Slovenia. The company also announced that its newly cr…
    Endpoints · 2mo agoDealPositive↗ source