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Pharma News
Pharma News
FDA Rejects Cytisinicline NDA Due to Manufacturing Issues, Not Safety
Achieve Life Sciences faces an FDA NDA rejection for cytisinicline over third-party manufacturing issues, but clinical safety and efficacy remain uncompromised.
Preclinical Oncology Models Improve Drug Toxicity Prediction in Trials
Emerging human-based preclinical models improve drug toxicity prediction in oncology, offering complementary tools to traditional animal testing in trials.
Epidermolysis Bullosa Treatment: FDA Grants Fast Track to TolaSure Gel
BioMendics announces that the US FDA has granted Fast Track Designation to BM-3103 (TolaSure Gel) for treating epidermolysis bullosa simplex.
US Biotech Job Market Gains: Pharma Collaborates on Onshoring Talent
At BIO 2026, leading US biopharma manufacturers establish regional training networks to manage rising onshoring talent and employment demands.
Skin Cancer Prevention and Treatment: bioAffinity Reveals siRNA Data
BioAffinity Technologies announces successful preclinical in vitro results using targeted siRNA platforms to eliminate common skin cancer cells.
Proteina Signs Parkinson's Disease Biomarkers Deal With Top US Pharma
Proteina finalizes a strategic analytics service contract with a US pharma company to track protein complexes in preclinical neurodegeneration studies.
Thalidomide Shows Potential for Treating Brain Vascular Malformations
Researchers at Capital Medical University demonstrate that thalidomide can stabilize rare central nervous system vascular malformations (CNS-AVMs).
Atopic Dermatitis Topical Treatments: DB-006 Outperforms Rivals
Derm-Biome's novel topical small molecule DB-006 demonstrates superior preclinical efficacy, reducing itch, inflammation, and S. aureus bacteria.
Mesothelioma Targeted Therapy: Amivantamab Dual Targeting Preclinical Data
A new study explores amivantamab, a dual EGFR and MET bispecific antibody, as an innovative targeted therapy option for diffuse pleural mesothelioma.
FDA Priority Review Voucher: Denali Sells Regulatory Pass for $195M
Denali Therapeutics sells its priority review voucher for $195 million to advance its blood-brain barrier neurodegenerative pipeline development.
Multiple Myeloma New Treatment: Sarclisa Wins MHRA Approval for OBI Use
Sanofi’s Sarclisa (isatuximab) achieves UK MHRA approval as the first multiple myeloma anti-cancer therapy administered via on-body injector.
Global Clinical Trials: Avance Clinical Expands APAC & China CRO Operations
Announced at BIO 2026, global Contract Research Organization Avance Clinical expands its biotech trial footprint into Singapore, Malaysia, and China.
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