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Pharma News
Pharma News
India says AI will transform drug discovery and pharma regulation
India’s Department of Pharmaceuticals said AI is reshaping drug discovery, clinical development, regulation and post-market safety monitoring.
Biogen boosts rare disease pipeline with $5.6bn Apellis buyout deal
Biogen agreed to acquire Apellis for $5.6 billion, adding Syfovre and Empaveli and strengthening its rare disease and immunology pipeline.
FDA approves Lilly’s Foundayo GLP-1 weight loss pill with fewer rules
Eli Lilly’s Foundayo won FDA approval as a GLP-1 weight loss pill that can be taken without food and water restrictions, expanding obesity treatment options.
Rare disease advocates urge Trump team to restore FDA clarity now
A rare disease coalition urged the Trump administration to restore FDA clarity as leadership changes loom at the biologics review center.
FDA grants RMAT to allogeneic CAR T therapy for R/R multiple myeloma
FDA granted RMAT designation to CB-011 for relapsed or refractory multiple myeloma, supporting faster development and potential accelerated approval.
Voro Therapeutics to present PrimeBody and VOR-101 data at AACR 2026
Voro Therapeutics will present new preclinical PrimeBody and VOR-101 data at AACR 2026 and AET Europe, highlighting tumor-activated biologics.
New Phase II enpatoran safety data support Phase III in cutaneous lupus
New Phase II data presented at SLEuro 2026 support enpatoran’s Phase III development in cutaneous lupus and systemic lupus erythematosus.
Lucid-MS moves closer to U.S. clinical trial for multiple sclerosis
Quantum Biopharma plans to seek FDA clearance for a Phase 2 U.S. trial of Lucid-MS, an oral therapy aimed at myelin repair in multiple sclerosis.
FDA approves new high dose SPINRAZA regimen for spinal muscular atrophy
Biogen announced FDA approval of the high dose SPINRAZA regimen for spinal muscular atrophy, expanding treatment options for SMA patients.
HLB experimental bile duct cancer drug gets FDA fast-track review
HLB said the FDA granted priority review to lirafugratinib for bile duct cancer, with a decision expected by Sept. 27.
Lilly expands AI drug development with Insilico deal worth up to $2.75B
Eli Lilly deepens its AI drug discovery strategy through a new Insilico Medicine partnership worth up to $2.75 billion in milestones and royalties.
Recordati Considers €10.9B CVC Capital Acquisition Offer Before Q1 Close
Italian pharma Recordati weighs a €10.9bn acquisition offer from CVC Capital. Discover the details of this major M&A deal ahead of the Q1 2026 close.
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