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Guardant Health's Guardant360 CDx wins FDA approval as companion diagnostic for Boehringer Ingelheim's Hernexeos targeting HER2-mutant non-small cell lung cancer
Small molecule, cancer, non-small cell lung cancer, HER2, companion diagnostic, liquid biopsy - Read more

Akeso's gumokimab (AK111) wins NMPA approval for moderate-to-severe plaque psoriasis following Ph3 success
Antibody, autoimmune, monoclonal antibody, plaque psoriasis, IL-17 inhibitor - Read more

Roche wins EU approval for label expansions of Ventana MMR RxDx companion diagnostic cancer platform
Companion diagnostic, oncology, regulatory, competitive - Read more

Simcere Pharmaceutical, Stanford Medicine collaborate to develop first-in-class therapies for idiopathic pulmonary fibrosis
Research collaboration, respiratory disease, rare disease, small molecule, licensing deal - Read more

Ildong Pharmaceutical, Welt partner to develop AI-driven digital therapeutics combining pharma products with DrugOS platform
Co-development, AI/ML, digital health, drug discovery, commercialization, licensing deal - Read more

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Novartis' (delpacibart braxlosiran) meets primary endpoints in Ph1/2 trial for facioscapulohumeral muscular dystrophy
RNA therapy, neuromuscular disease, antibody-oligonucleotide conjugate, facioscapulohumeral muscular dystrophy, DUX4 - Read more

Enliven Therapeutics' ELVN-001 shows improved Ph1 efficacy in heavily pretreated chronic myeloid leukemia patients ahead of Ph3
Small molecule, cancer, tyrosine kinase inhibitor, chronic myeloid leukemia, BCR::ABL1 - Read more

Kyntra Bio Ph3 data shows (roxadustat) improves transfusion independence in lower-risk myelodysplastic syndromes regardless of ring sideroblast status
Small molecule, cancer, HIF1-alpha inhibitor, myelodysplastic syndromes, anemia, roxadustat - Read more

Neion Bio raises $23M Series A to advance biologics manufacturing platform, expand pipeline
Biologics manufacturing, platform technology, biosimilars, genetic engineering - Read more

Human Continuum closes $5.13M seed round to advance exosome-based longevity and regenerative medicine platform
Exosome therapy, regenerative medicine, longevity, diagnostics, musculoskeletal, platform technology - Read more

Enliven Therapeutics prices upsized $400M public offering of common stock and pre-funded warrants
Clinical-stage, small molecule, oncology - Read more

Beneluxa Initiative calls for unified European pharma framework amid US drug pricing pressure on EU nations
Pharmaceutical pricing, healthcare policy, strategic, financial - Read more

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Jazz Pharmaceuticals, PharmaMar's Zepzelca (lurbinectedin) fails Ph3 overall survival endpoint in metastatic small cell lung cancer
Small molecule, cancer, chemotherapy, small cell lung cancer, combination therapy, second-line treatment - Read more

Amgen enlists Duke Clinical Research Institute to defend Tavneos against FDA withdrawal push
Small molecule, rare disease, regulatory, competitive - Read more

FDA issues second complete response letter to Camurus for Oclaiz (octreotide) targeting acromegaly over manufacturing concerns
Small molecule, metabolic disease, acromegaly, octreotide, long-acting formulation, FDA complete response letter - Read more

Sensorion drops OTOF gene therapy after Regeneron Pharmaceuticals' free Otarmeni approval, pivots to GJB2-targeting SENS-601
Gene therapy, rare disease, competitive, strategic - Read more

Summit Therapeutics pulls $500M secondary share sale, citing market conditions
Oncology, lung cancer, antibody, clinical-stage - Read more

FDA imposes import alert on Dabur India over GMP violations, bird droppings, and falsified manufacturing records
Small molecule, OTC medicines, regulatory, operational, data integrity - Read more

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