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Roche Strengthens Diagnostics Portfolio with New Multiplex PCR Assay
Roche has announced the availability of its cobas MPX-E assay, a qualitative in-vitro diagnostic test designed to simultaneously detect and differentiate HIV-1, HIV-2, Hepatitis B, C, and E viruses.
Meiji Seika Pharma Invests in Centivax for Universal Vaccine Platform
Meiji Seika Pharma invests in Centivax to advance a next-generation universal vaccine platform, with lead candidate Centi-Flu 01 currently in a Phase 1 influenza study.
Sobi Advances Tryngolza Expansion with EMA Validation for sHTG
Sobi has announced that the European Medicines Agency (EMA) has validated its application to expand the indication of Tryngolza (olezarsen) for the treatment of adults with severe hypertriglyceridemia (sHTG), defined by triglyceride levels ≥880 mg/dL (≥10 mmol/L).
NMPA Nod for GSK's Exdensur Boosts Biologics Manufacturing Momentum
GSK plc has received approval from China’s National Medical Products Administration (NMPA) for Exdensur (depemokimab) as an add-on maintenance therapy for severe asthma with an eosinophilic phenotype in patients aged 12 years and above.
Biocytogen Grants Licence for RenNano Platform to Taisho Pharmaceutical
Biocytogen licenses its RenNano platform to Taisho Pharmaceutical to advance fully human heavy chain-only antibody discovery, supporting in-vivo screening and downstream research.
Alembic Pharmaceuticals Secures US FDA Approval for Paroxetine ER Tablets
U.S. Food and Drug Administration grants final approval to Alembic’s sANDA for paroxetine extended-release tablets, used in treating depression and anxiety-related disorders.
Arletta Pharma Reports Positive Phase II Results for Lybrido in Female Sexual Arousal Disorder
Study shows significant improvement in physiological arousal markers, supporting further development of testosterone-sildenafil combination therapy for FSIAD.
European Medicines Agency Recommends Ending Use of Tecovirimat SIGA for Mpox Treatment
CHMP review finds no clinical benefit in mpox patients, while other approved uses of the antiviral remain unaffected.
Eisai and Nuvation Bio Secure EMA Validation for Taletrectinib in Lung Cancer
EU regulator begins review of next-generation targeted therapy for advanced ROS1-positive non-small cell lung cancer.
Eli Lilly and Company's Ebglyss Shows Four-Year Durable Relief in Atopic Dermatitis Study
Long-term phase III data reveal sustained skin clearance and itch reduction with once-monthly dosing in eczema patients.
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