Roche’s new vaginitis PCR test is FDA-cleared, but the real commercial test starts inside laboratories
Roche’s cobas BV/CV assay gains FDA clearance for combined BV and Candida testing, setting up a 2026 U.S. laboratory launch.
Roche’s cobas BV/CV assay gains FDA clearance for combined BV and Candida testing, setting up a 2026 U.S. laboratory launch.
Roche Holding AG has discontinued development of tominersen and RG6496, removing two investigational huntingtin-lowering medicines from its neurology pipeline after separate setbacks emerged almost simultaneously. The Phase 2 GENERATION HD2 trial showed that tominersen lowered important biological markers but did not meaningfully slow clinical decline, while the Phase 1 POINT-HD study of RG6496 was halted
Teva gains broad rights to PB018 as Polpharma Biologics advances an Ocrevus biosimilar into clinical development for multiple sclerosis.
Beckman Coulter Diagnostics has secured European clearance for its automated Access p-Tau217 blood test, potentially widening access to Alzheimer’s biomarker testing while raising questions about reimbursement, intermediate results and clinical interpretation.
Discover why Roche and Otsuka-owned Astex are pursuing a $515 million cell-cycle breast cancer programme and what risks remain.
Discover why Lineage Cell Therapeutics’ OpRegen and OPC1 programmes now face critical delivery, trial design and manufacturing tests.
Find out how AbbVie’s nine-year venetoclax CLL data could reshape fixed-duration treatment decisions and long-term leukemia care.
Find out how Roche’s giredestrant FDA priority review could reshape endocrine therapy in early breast cancer.
Roche wants AI pathology at scale. PathAI gives it the tissue-analysis layer needed to tighten diagnostics, trials, and precision oncology.
Genentech’s Enspryng cut MOGAD relapse risk by 68% in Phase III. Read what the data could mean for regulators, clinicians, and the rare disease market.