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316 stories matching this filter · ← front page

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  • FDA grants early approval to RevMed's pancreatic cancer drug Rasonque
    FDA granted early approval to Revolution Medicines' daraxonrasib, now named Rasonque, for pancreatic adenocarcinoma, arriving 6.5 months before the FDA deadline. The oral RAS inhibitor demonstrate…
    BioSpace · 3h agoApprovalPositive↗ 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 · 5h agoPositive readoutPositive↗ source
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Infectious Disease380
  • Jazz's Ziihera receives FDA approval for first-line treatment of HER2-positive gastroesophageal cancer
    The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals' bispecific antibody Ziihera for use as a first‑line therapy in patients with unresectable locally advanced or metastatic gas…
    BioSpace · 6h agoApprovalPositive↗ source
  • FDA approves Revolution Medicines' daraxonrasib for second-line pancreatic cancer
    The U.S. Food and Drug Administration announced approval of Revolution Medicines' drug daraxonrasib for patients with pancreatic cancer who have already received prior therapy. The approval marks…
    Endpoints · 3h agoApprovalPositive↗ 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 · 7h agoPositive readoutPositive↗ source
  • FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy review
    The FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…
    BioSpace · 8h agoRegulatoryNeutral↗ source
  • FDA greenlights Revolution Medicines' pancreatic cancer gamechanger
    Following dynamite data that earned a standing ovation at the American Society of Clinical Oncology meeting in May, Revolution Medicines’ Ras inhibitor daraxonrasib has been approved by the FDA for…
    Fierce Biotech · 7h ago↗ source
  • Akeso CEO looks beyond lung cancer with biliary tract win, counters ivonescimab debate
    Fresh off a phase 3 win in biliary tract cancer, Akeso CEO Michelle Xia, Ph.D., is touting the PD-1xVEGF bispecific antibody ivonescimab’s ability beyond non-small cell lung cancer, even as she con…
    Fierce Biotech · 7h ago↗ source
  • FDA expands Jazz's Ziihera use to frontline gastric cancer
    FDA granted approval for Jazz Pharmaceuticals' bispecific antibody Ziihera as a frontline treatment for certain gastric cancer patients. This is the first time Ziihera will be marketed to newly di…
    Endpoints · 1d agoApprovalPositive↗ source
  • Curium seeks FDA review of rival radioligand therapy to boost supply resilience against Novartis' Pluvicto
    Curium is preparing to challenge Novartis' dominant prostate cancer radioligand therapy, Pluvicto, by entering discussions with the FDA about reviewing its own PSMA‑directed Lu‑177 candidate. Nova…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • FDA expands labels for J&J’s Imaavy and Jazz’s Ziihera; Teva under Turkish antitrust probe
    The U.S. Food and Drug Administration has broadened the approved uses for Johnson & Johnson’s oncology drug Imaavy and Jazz Pharmaceuticals’ Ziihera, adding new indications to each label. These la…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on potency testing for immunotherapy products
    The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…
    raps · 1d agoRegulatoryNeutral↗ source
  • Amgen and academic centers discuss FDA pilot to accelerate first-in-human trials
    The U.S. Food and Drug Administration is working with industry and research institutions on a pilot program aimed at speeding first-in-human studies. The effort is intended to counter the rapid tim…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Labcorp introduces reflex hepatitis D test to improve detection of severe viral hepatitis
    Labcorp has launched a new hepatitis D (HDV) reflex testing option as part of its Comprehensive Hepatitis Testing portfolio, aiming to close a gap in HDV monitoring. The test automatically adds HD…
    Fierce Biotech · 1d agoPositive↗ 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 · 1d agoLayoffsNegative↗ source
  • McKesson strikes $2.25B deal to snap up Precision Medicine Group
    The healthcare conglomerate, which ranks eighth on the Fortune 500 list, is set to envelop privately held Precision Medicine Group into its oncology branch as part of an ongoing effort to grow its…
    Fierce Biotech · 1d ago↗ source
  • Roche signs $2.5 billion deal with Hanmi for experimental obesity drug targeting muscle loss
    Roche's Genentech unit has agreed to acquire global rights (outside South Korea) to Hanmi's clinical-stage urocortin-2 analog, HM17321, as part of a deal valued up to $2.5 billion. The agreement i…
    Fierce Biotech · 2d agoDealPositive↗ source
  • FDA places hold on REGENXBIO's Hunter syndrome gene therapy after spinal nodules found, company pauses resubmission
    The FDA placed a clinical hold on RGX-121, REGENXBIO's gene therapy for Hunter syndrome, after MRI scans showed small nodules or cystic masses in the spines of five trial participants. The finding…
    BioSpace · 2d agoRegulatoryNegative↗ source
  • FDA places clinical hold on Regenxbio’s RGX-121 gene therapy after spine MRI findings, delaying refiling plans
    The U.S. Food and Drug Administration has issued a clinical hold on Regenxbio’s gene therapy candidate RGX-121 after routine MRI scans revealed asymptomatic changes in the spines of trial participa…
    Fierce Biotech · 2d agoRegulatoryNegative↗ source
  • TME Pharma narrows licensing talks for brain-cancer drug NOX-A12, eyes $1 billion market
    TME Pharma, a German biotech, says it has narrowed potential partners for its experimental glioblastoma therapy NOX-A12, a CCL2 inhibitor, to two firms and entered a final evaluation phase. The co…
    Fierce Biotech · 2d agoDealNeutral↗ source
  • Merck and Moderna report positive topline results for personalized cancer vaccine
    A third death was reported in China’s expedited clinical trials, raising safety concerns for fast‑track studies in the region. Merck and Moderna announced positive topline data from their personal…
    Endpoints · 4d 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 · 5d agoRegulatoryNegative↗ source
  • Werewolf Therapeutics merges with Ambros in $150M deal to advance non‑opioid painkiller for rare limb injury syndrome
    Werewolf Therapeutics and Ambros Therapeutics announced a merger valued at $150 million, creating a new company that will retain the Ambros name. The deal includes a private placement to fund the…
    BioSpace · 5d agoDealPositive↗ source
  • New study warns that Trump-era cuts to federal research could jeopardize cancer drug development
    A recent study examines how recent political moves to curtail federally funded research could affect cancer drug development. The analysis notes that over the past decade biopharma companies have…
    Endpoints · 5d 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 · 6d agoPositive readoutPositive↗ source