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Cosette Pharmaceuticals wins FDA approval for Evoxac (cevimeline) liquid formulation targeting dry mouth in Sjögren's disease
Small molecule, autoimmune, Sjögren's disease, muscarinic agonist, dry mouth, 505(b)(2) - Read more

GSK's Jemperli (dostarlimab) receives FDA accelerated approval for MSI-H/dMMR locally advanced rectal cancer based on Ph2 data
Antibody, cancer, monoclonal antibody, colorectal cancer, PD-1 inhibitor, MSI-H/dMMR biomarker - Read more

Japan's MHLW approves Sanofi's CirCLIQ injector delivering Sarclisa (isatuximab) via Enable Injections' enFuse system for multiple myeloma
Antibody, cancer, monoclonal antibody, multiple myeloma, subcutaneous delivery, combination therapy - Read more

AstraZeneca, Oracle partner to improve clinical trial recruitment using AI across multiple disease areas
Research collaboration, AI/ML, clinical trials, drug discovery, data analytics - Read more

Eli Lilly, METiS TechBio partner on AI-driven LNP drug delivery platform, up to $1.1B milestones
Licensing deal, AI/ML, drug delivery, lipid nanoparticles, milestone payments, royalties - Read more

Samsung Bioepis, Bahiafarma, Bionovis ink 10-year eculizumab biosimilar supply deal for Brazil's public health system
Manufacturing agreement, rare disease, biosimilar, technology transfer, public health - Read more

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Nano24's EXO-CD24 (exosome-CD24) meets primary endpoint in Ph2b acute respiratory distress syndrome study
Protein therapy, respiratory, exosome therapy, acute respiratory distress syndrome, CD24, immunomodulation - Read more

Amgen, AstraZeneca's Tezspire (tezepelumab) achieves histologic remission in Ph3 eosinophilic esophagitis trial
Antibody, autoimmune, monoclonal antibody, eosinophilic esophagitis, Tezspire, TSLP - Read more

Gilead Sciences' (emvistegrast) meets Ph2 primary endpoint in moderately to severely active ulcerative colitis, Ph3 planned
Small molecule, autoimmune, integrin inhibitor, ulcerative colitis, inflammatory bowel disease - Read more

Rapport Therapeutics' (RAP-219) meets primary endpoint in Ph2 trial targeting TARPγ8 for acute bipolar mania
Small molecule, neurological, bipolar disorder, TARPγ8 inhibitor, AMPA receptor - Read more

Eli Lilly's Omvoh (mirikizumab-mrkz) meets Ph3 primary endpoint in pediatric ulcerative colitis, first IL-23p19 inhibitor to do so
Antibody, autoimmune, monoclonal antibody, ulcerative colitis, IL-23p19 inhibitor, pediatric patients - Read more

Lycia Therapeutics plans $228M IPO to advance protein degrader pipeline for food allergy
Autoimmune, protein degrader, allergic disease, clinical-stage - Read more

Epicrispr Biotechnologies receives $8M CIRM grant to advance EPI-321 FSHD epigenetic therapy
Epigenetic therapy, rare disease, neuromuscular, gene modulation, clinical-stage - Read more

Prolific Machines holds initial closing of $50M Series B2, advancing biologics biomanufacturing platform
Biomanufacturing, CDMO, optogenetics, biologics, AI-driven, platform technology - Read more

TCGX takes migraine biotech TriGemX Bio public via SPAC, raising $246M for phase 3 elismetrep trials
Small molecule, migraine, SPAC, major transaction - Read more

Ambrose Healthcare acquires AM-Pharma for up to €161M ($180.5M), expanding rare disease pipeline and gaining European base
Enzyme replacement therapy, rare disease, major transaction, strategic - Read more

Antheia lands $80M conditional loan from Trump administration to onshore U.S. drug manufacturing
Biosynthesis platform, drug supply chain, strategic, major transaction - Read more

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EyePoint halves workforce, ends wet AMD trials early after duravyu fails Phase 3 again
Small molecule, ophthalmology, cost reduction, strategic - Read more

Pfizer halts Ph2 trial of (PF-06835375) targeting CXCR5 for primary immune thrombocytopenia due to business decision
Antibody, autoimmune, monoclonal antibody, immune thrombocytopenia, CXCR5 - Read more

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