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177 stories matching this filter · ← front page

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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 · 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 · 4h agoPositive readoutPositive↗ source
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73
fda recalls67
fda medwatch60
fda press38
1122
Psychiatry & CNS862
Ophthalmology494
Pain473
Endocrinology & Metabolism466
Infectious Disease444
  • 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 · 13h agoLayoffsNegative↗ 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
  • Novartis' Lp(a) drug pelacarsen fails to cut heart attack or stroke risk in phase 3 trial
    Novartis, in partnership with Ionis, completed the phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide designed to lower lipoprotein(a) levels. The study enrolled more than 8,30…
    Fierce Biotech · 3d agoNegative readoutNegative↗ 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 · 3d 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 · 4d 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 · 4d agoPositive readoutPositive↗ source
  • Pfizer sells Seagen-derived ADC to Medicus Pharma for $12 million upfront, potential $1 billion milestones
    Pfizer has transferred rights to an antibody‑drug conjugate it acquired in its Seagen purchase to Medicus Pharma. Medicus will pay $12 million upfront and $15 million a year later, and Pfizer coul…
    Fierce Biotech · 5d agoDealPositive↗ source
  • GSK agrees $1.3 billion deal with Hutchmed for early-stage KRAS-EGFR cancer candidate
    GSK will pay $110 million upfront to Hutchmed as part of a deal that could reach $1.295 billion, giving GSK worldwide rights to develop and commercialize a preclinical oncology asset. The asset, i…
    Fierce Biotech · 5d agoDealPositive↗ 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 · 4d 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 · 4d 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
  • TScan Therapeutics cuts 75% of staff to focus on preclinical solid tumor programs
    TScan Therapeutics said it will cut about three quarters of its workforce after pausing its hematological and autoimmune programs. The company will shift resources to its preclinical solid tumor p…
    Fierce Biotech · 6d agoLayoffsNegative↗ 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 · 6d 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 · 11d 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 · 12d 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
  • Akeso reports phase 3 overall survival win for ivonescimab in advanced biliary tract cancer
    Akeso announced that its bispecific antibody ivonescimab combined with chemotherapy improved overall survival in a China phase 3 trial for advanced biliary tract cancer, beating the standard regime…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • Inhalable modified tRNA restores lung protein function in cystic fibrosis mice, shows promise for genetic diseases
    University of Toronto scientists have shown that an inhalable form of modified transfer RNA can safely reach the lungs of mice carrying a nonsense mutation that causes cystic fibrosis. The treatmen…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source