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139 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 · 1h agoPositive readoutPositive↗ source
  • Novo Nordisk halts two more late-stage heart failure trials, calling IL-6 an invalid target
    Novo Nordisk said it is ending two late-stage heart-failure studies, HERMES and ATHENA, that were testing its IL-6 inhibitor ziltivekimab. The company cited a recommendation from the Data Monitorin…
    BioSpace · 2h agoNegative readoutNegative
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fda recalls67
fda medwatch60
fda press38
Psychiatry & CNS866
Ophthalmology494
Pain478
Endocrinology & Metabolism471
Infectious Disease444
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  • 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 · 6h agoPositive readoutPositive↗ 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
  • Beam Therapeutics reports one-year data from early-stage AATD gene therapy trial
    Beam Therapeutics released new results from its early-stage gene-editing program targeting alpha-1 antitrypsin deficiency (AATD), a rare condition that can damage the lungs and liver. The data com…
    Endpoints · 8h agoPositive readoutPositive↗ 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 · 17h agoLayoffsNegative↗ 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
  • 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
  • Summit and Akeso's ivonescimab beats Merck's Keytruda in Chinese NSCLC trial
    Summit Therapeutics and Akeso reported that their bispecific PD-1/VEGF antibody ivonescimab outperformed Merck's Keytruda in a Phase 3 HARMONi-2 trial conducted in China. The study enrolled first‑l…
    BioSpace · 5d agoPositive readoutPositive↗ source
  • Revolution Medicines' Rasonque shows 42% response and 16-month survival in NSCLC subgroup
    Data from a subgroup of an earlier trial, described by Truist Securities as the most relevant to Revolution Medicines' ongoing Phase 3 study, reported a 42% overall response rate and a median overa…
    BioSpace · 5d agoPositive readoutPositive↗ source
  • GSK pays $110 million upfront for exclusive rights to HUTCHMED’s dual-target cancer therapy HMPL-A830
    GSK announced a partnership with Hong Kong-based HUTCHMED, paying $110 million upfront for exclusive global rights to develop HMPL-A830. HMPL-A830 is an investigational antibody-targeted therapy c…
    BioSpace · 5d agoDealPositive↗ source
  • Pfizer grants Medicus co-development rights to CD228-targeted ADC PF-08046031
    Pfizer announced it is transferring co-development rights for its CD228-targeted antibody-drug conjugate, PF-08046031, to Medicus Pharma. The ADC, originally discovered by Seagen, will now be adva…
    Endpoints · 5d agoDealNeutral↗ source
  • Novartis and BMS pause CAR‑T trials after patient deaths while Revolution Medicines gains early FDA approval for pancreatic cancer drug
    Novartis has placed several trials of its CAR‑T therapy rapcabtagene autoleucel on hold after three patients receiving the treatment died. Bristol Myers Squibb also voluntarily froze its autoimmun…
    BioSpace · 6d agoRegulatoryNeutral↗ source
  • BMS faces steep risk if milvexian trial fails, could spark mega-cap merger frenzy
    BMS is heading toward a readout for its oral FXIa inhibitor milvexian, a trial that analysts say could be pivotal for the company's future growth. The recent collapse of merger talks with AstraZen…
    BioSpace · 6d agoNegative readoutNegative↗ source
  • GSK to start Phase 3 trial of mRNA flu vaccine after strong mid-stage results
    GSK announced it will begin a Phase 3 trial of its mRNA-based influenza vaccine, with enrollment slated to start in September. In a Phase 2 study of 971 adults, the investigational vaccine, which…
    BioSpace · 7d agoPositive readoutPositive↗ source
  • Revolution Medicines' Rasonge receives second-line pancreatic cancer nod, could drive $2.3B sales by 2028
    Revolution Medicines announced that its RAS inhibitor Rasonge earned a second-line indication for pancreatic ductal adenocarcinoma, marking the first regulatory step in the company's PDAC strategy.…
    BioSpace · 12d agoApprovalPositive↗ source
  • AstraZeneca and Amgen’s Tezspire shows positive results in Phase 3 eosinophilic esophagitis trial
    AstraZeneca and Amgen continue to co‑develop and co‑commercialize Tezspire, an anti‑inflammatory therapy already approved for asthma and chronic rhinosinusitis. The partners are preparing another F…
    BioSpace · 12d agoPositive readoutPositive↗ source
  • Generate Bio drops as data accidentally leaked ahead of European conference
    Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
    BioSpace · 12d agoRegulatoryNeutral↗ source
  • Generate:Biomedicines shares early Phase 1 respiratory data after ERS poster leak
    Generate:Biomedicines presented Phase 1 data for its respiratory disease candidate at the European Respiratory Society annual meeting. The presentation came after the conference posters were releas…
    Endpoints · 12d agoNeutral↗ source
  • Summit Therapeutics and Akeso report Phase 3 survival benefit for ivonescimab in Chinese biliary tract cancer
    Summit Therapeutics and its Chinese partner Akeso said their bispecific antibody ivonescimab combined with chemotherapy improved overall survival for patients with first-line biliary tract cancer i…
    BioSpace · 13d agoPositive readoutPositive↗ source
  • Akeso and Summit report ivonescimab meets primary endpoint in China Phase 3 biliary tract cancer trial
    Akeso Therapeutics and partner Summit Therapeutics announced that their bispecific antibody ivonescimab achieved the primary efficacy endpoint in a Phase 3 study conducted exclusively in China. Th…
    Endpoints · 13d agoPositive readoutPositive↗ source
  • US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deaths
    Three recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…
    BioSpace · 18d agoRegulatoryNegative↗ source
  • Merck and Moderna’s melanoma vaccine shows positive Phase 3 results, boosting investor confidence
    Merck and Moderna announced that their personalized melanoma vaccine met the primary endpoint of recurrence‑free survival in a Phase 3 trial when given together with Keytruda. The study showed pati…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • Pediatric rare cancer research draws steady investment despite biotech market volatility
    The article notes that pediatric rare cancers continue to attract investment because they address the greatest unmet medical needs and allow clear measurement of patient impact. Even as the biotec…
    BioSpace · 19d agoPositive↗ source
  • Biokin's EGFR-HER3 bispecific ADC succeeds in late-stage Chinese lung cancer trial
    Chinese biotech Biokin announced that its EGFRxHER3 bispecific antibody-drug conjugate met its primary endpoint in a late-stage trial in a genetically defined subset of non-small cell lung cancer (…
    Endpoints · 20d agoPositive readoutPositive↗ source