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2,306 stories matching this filter · ← front page

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  • Research on orexin and narcolepsy earns Lasker Award for Yanagisawa and Mignot
    Masashi Yanagisawa and Emmanuel Mignot were honored with the Lasker Award for their work uncovering the role of orexin in narcolepsy. The award was announced on September 9, 2026. Their research b…
    Endpoints · 2mo agoPositive↗ source
  • Compass Pathways reports positive one-year data for its psilocybin therapy COMP360
    Compass Pathways released results from a one-year study of its psilocybin‑based therapy COMP360. The company described the data as positive, indicating continued promise for the investigational tre…
    Endpoints · 2mo agoPositive readoutPositive↗ source
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  • 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
  • TwoStep Therapeutics raises $62.5 million Series A backed by Pfizer and Merck KGaA venture groups
    TwoStep Therapeutics, a cancer biotech, announced a $62.5 million Series A financing to advance its novel approach to antibody-drug conjugates and radioligand therapies. The round was supported by…
    Endpoints · 2mo agoDealPositive↗ source
  • Kura Oncology spins out diabetes program into new company with $50M funding and Lilly support
    Kura Oncology, known for its leukemia menin inhibitor Komzifti, announced it is separating its diabetes research into a newly formed company. The new entity will receive $50 million in financing,…
    Endpoints · 2mo agoDealPositive↗ source
  • 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
  • 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
  • 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