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Pharma News
Pharma News
Aspect Biosystems gains C$79m for cellular medicine development
Aspect Biosystems secured C$79 million from Canada to support a multi-year cellular medicine project for endocrine and metabolic diseases.
SK biopharm to present NTSR1 radiopharmaceutical data at AACR 2026 meeting
SK biopharmaceuticals will present preclinical data on SKL35501 and SKL35502 at AACR 2026, highlighting its NTSR1-targeted theranostics strategy.
Teva wins FDA approval for Ponlimsi Prolia biosimilar in the U.S.
Teva received FDA approval for Ponlimsi, a Prolia biosimilar, while FDA and EMA accepted filings for its proposed Xolair biosimilar.
FDA fully approves Tecartus for relapsed or refractory mantle cell lymphoma
FDA granted full approval to Tecartus for adults with relapsed or refractory mantle cell lymphoma, expanding use beyond prior BTK inhibitor exposure.
Bio Solutions advances FDA codeine screening with fingerprint study
Intelligent Bio Solutions completed a fingerprint-based codeine screen study, supporting a planned FDA 510(k) submission for U.S. clearance.
Adagene and Incyte launch MSS colorectal cancer combination trial
Adagene and Incyte will start a Phase 1 trial in 2026 testing muzastotug with INCA33890 in third-line MSS colorectal cancer patients.
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.
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