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SimBioSys wins FDA clearance for Nvidia-powered, MRI-based AI breast cancer recurrence risk tool
AI diagnostic tool, oncology, regulatory, operational - Read more

Roche's Enspryng (satralizumab) wins FDA approval for thyroid eye disease, targeting interleukin-6 receptor following Ph3 data
Antibody, autoimmune, monoclonal antibody, thyroid eye disease, IL-6 receptor inhibitor - Read more

Revolution Medicines' daraxonrasib receives positive CHMP opinion for metastatic pancreatic cancer EU approval
Small molecule, oncology, regulatory, competitive - Read more

Eli Lilly's oral weight-loss pill Foundayo wins EU regulator backing for obesity and type 2 diabetes
Small molecule, obesity, regulatory, competitive - Read more

UCB's Zilbrysq (zilucoplan) autoinjector receives FDA approval for generalized myasthenia gravis self-administration
Protein therapy, autoimmune, generalized myasthenia gravis, complement inhibitor, anti-AChR antibody positive, autoinjector - Read more

CHMP recommends Johnson & Johnson's Talvey (talquetamab) plus daratumumab for relapsed/refractory multiple myeloma from second line
Antibody, cancer, bispecific antibody, multiple myeloma, GPRC5D, combination therapy - Read more

Kindeva lands $226M DoD contract to supply nerve agent antidote autoinjectors to U.S. military
Manufacturing agreement, small molecule, infectious disease, defense contract - Read more

Senturi Pharma, Digestive Care sign exclusive European distribution agreement for PERTZYE pancrelipase
Exclusive distribution, gastrointestinal, small molecule, commercialization, rare disease - Read more

IBA, Framatome form Ekalia joint venture to industrialize Astatine-211 production for cancer therapies
Joint venture, oncology, radiopharmaceuticals, manufacturing, alpha therapy - Read more

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GeneCradle's GC101 (AAV) meets primary and key secondary endpoints in Ph3 trial for 5q spinal muscular atrophy
Gene therapy, neurological, AAV vector, spinal muscular atrophy, intrathecal administration, rare disease - Read more

Estuary Biotherapeutics emerges from stealth with $103M to advance gene therapies for autosomal dominant polycystic kidney disease
Rare disease, gene therapy, kidney disease, AAV, clinical-stage - Read more

City Therapeutics raises $200M IPO, advancing next-gen RNAi therapies pipeline
RNAi, cardiovascular, rare disease, clinical-stage, platform technology - Read more

Acta Pharmaceuticals raises $24M Seed funding to advance Alzheimer's early intervention therapies
Alzheimer's disease, small molecule, neurological, clinical-stage, platform technology - Read more

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China proposes export ban on foreign acquisitions of cell therapy, siRNA, and gain-of-function biopharma platforms
Cell and gene therapy, rare disease, regulatory, strategic, competitive - Read more

FDA issues warning letter to Eurofins over selective test result recording compromising data integrity
Contract testing, data integrity, regulatory, operational - Read more

FDA issues early alert for Edwards Lifesciences' SAPIEN M3 mitral valve delivery system after death, injury reports
Medical device, cardiovascular, regulatory, operational - Read more

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