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541 stories matching this filter · ← front page

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  • Inhibrx’s OX40 agonist plus Keytruda shows 48% response rate, beating Keytruda alone in head and neck cancer Phase 2
    Inhibrx reported results from its Phase 2 HexAgon trial evaluating INBRX-106, an OX40 receptor agonist, combined with Merck’s Keytruda in patients with treatment‑naïve, PD‑L1‑positive metastatic or…
    BioSpace · 2h 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 · 1h agoRegulatoryNeutral↗ source
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fda recalls67
fda medwatch60
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Psychiatry & CNS866
Ophthalmology494
Pain478
Endocrinology & Metabolism473
Infectious Disease444
  • FDA approves AstraZeneca's oral SERD Etcamah for HR+/HER2-negative advanced breast cancer
    FDA granted approval to AstraZeneca's camizestrant, marketed as Etcamah, an oral selective estrogen receptor degrader (SERD) for a specific subset of advanced breast cancer patients. The indicatio…
    BioSpace · 4h agoApprovalPositive↗ source
  • BrainChild Bio secures $119M Series A to advance CAR-T therapy for deadly pediatric brain tumor
    BrainChild Bio announced a $119 million Series A financing round aimed at moving its CAR‑T programs for central nervous system cancers in children forward. The company’s lead candidate, BCB-276, w…
    BioSpace · 6h agoDealPositive↗ source
  • Moderna and Merck’s personalized mRNA cancer vaccine success spurs industry shift to faster, smaller-scale production
    After mastering large‑scale mRNA manufacturing during the COVID‑19 pandemic, the sector is now turning its attention to delivering individualized vaccines to patients quickly. The recent clinical…
    BioSpace · 12h agoPositive↗ source
  • Parkinson's drug pipeline diversifies as firms seek disease-modifying therapies
    Several pharmaceutical companies are shifting away from the traditional alpha-synuclein antibody strategy and exploring alternative mechanisms to treat Parkinson's disease. AC Immune is highlighted…
    BioSpace · 13h agoNeutral↗ source
  • Roivant's mosliciguat shows strong Phase 2 results, advancing to Phase 3 for PH-ILD
    Mosliciguat, the pulmonary hypertension candidate from Roivant Sciences subsidiary Pulmovant, cut pulmonary vascular resistance by more than 56% in a Phase 2 trial of patients with PH‑ILD, surpassi…
    BioSpace · 2h agoPositive readoutPositive↗ source
  • Bristol Myers reports Phase 2 success for GPRC5D‑directed CAR‑T therapy
    Bristol Myers announced positive Phase 2 results for its GPRC5D‑directed CAR‑T therapy aimed at treating multiple myeloma. The study demonstrated encouraging efficacy signals, adding to the growing…
    Endpoints · 2h agoPositive readoutPositive↗ source
  • Moonwalk Biosciences raises $70M to move RNAi obesity drug MW101 toward first-in-human trials in 2027
    Moonwalk Biosciences, an obesity drug developer backed by Eli Lilly, announced a $70 million Series B financing. The funding will support its lead RNAi candidate, MW101, which in mouse studies pro…
    BioSpace · 5h agoDealPositive↗ source
  • Inhibrx reports promising mid-stage data for OX40 agonist and plans vaccine combos early next year
    Inhibrx Biosciences announced that its OX40 agonist showed encouraging activity in a mid-stage trial involving immunogenic cancers. The data suggest the agent may also enhance responses when paire…
    Endpoints · 5h agoPositive readoutPositive↗ source
  • BrainChild Bio raises $116 million to fund pivotal pediatric brain tumor CAR-T trial
    BrainChild Bio, a Seattle-based biotech, announced it has secured $116 million in financing to support a pivotal clinical trial of its CAR-T therapy aimed at pediatric brain tumors. The funding ro…
    Endpoints · 6h agoDealPositive↗ source
  • Benelux’s strong science base eyed for biotech scaling despite funding gaps
    Belgium and the Netherlands have built some of Europe’s strongest life‑science ecosystems, anchored by leading research institutions and a growing pool of biotech talent. Early‑stage capital remai…
    BioSpace · 10h agoPositive↗ source
  • AI can transform drug discovery only when its strengths are properly leveraged
    The article notes a split narrative in the industry, with some headlines promising AI will speed drugs to market while others warn it could waste resources. Thomas M. Kaiser, a medicinal chemist,…
    BioSpace · 12h agoNeutral↗ source
  • FDA approves AstraZeneca’s Etcamah, opening ctDNA-guided treatment paradigm in breast cancer
    In a rare divergence from its own expert panel, the FDA has granted accelerated approval to AstraZeneca’s camizestrant, turning a contentious regulatory review into a landmark win that opens a new…
    Fierce Biotech · 7h ago↗ source
  • Bristol Myers’ pivotal CAR-T multiple myeloma trial hits primary endpoint
    A pivotal trial of Bristol Myers Squibb’s GPRC5D-directed CAR-T cell therapy has hit its primary endpoint, furthering the drugmaker’s efforts to challenge Johnson & Johnson for the post-BCMA multip…
    Fierce Biotech · 7h ago↗ source
  • Inhibrx CEO says progression-free survival data leave ‘no question’ about OX40 agonist’s durability
    Inhibrx Biosciences’ CEO has argued that the 9.6 months of progression-free survival demonstrated by its OX40 agonist in a phase 2 study has proven the therapy’s durability in treating head and nec…
    Fierce Biotech · 16h ago↗ source
  • FDA grants accelerated approval to AstraZeneca's oral SERD for breast cancer despite advisory panel opposition
    FDA granted accelerated approval to AstraZeneca's oral selective estrogen receptor degrader, Camizestrant, for a specific group of breast cancer patients. The approval was issued on Friday even th…
    Endpoints · 23h agoApprovalPositive↗ source
  • BrainChild Bio masterminds $116M series A for CAR-T's pivotal push in pediatric brain cancer
    A startup spawned from Seattle Children’s Hospital has raised a $116 million series A to advance cell therapies for devastating childhood brain tumors.
    Fierce Biotech · 1d agoNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 18h agoLayoffsNegative↗ source
  • Guardant wins FDA nod for diagnostic guiding use of AstraZeneca’s Etcamah
    Hot on the heels of the approval for AstraZeneca’s breast cancer drug Etcamah, Guardant Health has been given the green light for its companion diagnostic.
    Fierce Biotech · 1d ago↗ source
  • Roivant’s inhaled pulmonary hypertension drug mosliciguat shows strong Phase 2 results
    Roivant invested $14 million in Bayer's inhaled soluble guanylate cyclase activator mosliciguat after a $294 million biobucks agreement in 2024, and promptly advanced the candidate into a Phase 2 s…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • AbbVie’s etentamig shows strong survival and response gains in Phase 3 multiple myeloma trial
    AbbVie reported that its investigational bispecific T‑cell engager, etentamig, significantly reduced the risk of disease progression or death in a Phase 3 study of patients with relapsed or refract…
    BioSpace · 4d agoPositive readoutPositive↗ source
  • Pfizer transfers Seagen ADC PF-08046031 to Medicus, adds $12M upfront payment amid acquisition doubts
    Pfizer has moved primary responsibility for an investigational antibody‑drug conjugate, PF‑08046031, to Medicus Pharma as part of its $43 billion Seagen acquisition. Under the license, Medicus wil…
    BioSpace · 4d agoDealNegative↗ source
  • MassBio and SCbio select 10 life science startups for Drive accelerator
    MassBio and SCbio announced that ten early‑stage life‑science companies have been chosen for the fall cohorts of the Drive accelerator program. The selection includes five biotech firms and five te…
    BioSpace · 4d agoPositive↗ source
  • Akeso and Summit report ivonescimab meets overall survival endpoint in Phase 3 lung cancer trial
    Akeso and its partner Summit said the Phase 3 trial of ivonescimab, a PD-1xVEGF bispecific antibody, has met its overall survival endpoint in a selected group of lung cancer patients. The announcem…
    Endpoints · 5d agoPositive readoutPositive↗ source