The FDA has approved Tecentriq and Tecentriq Hybreza with a fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III dMMR colon cancer, based on the phase III ATOMIC trial.
The Roche fenebrutinib FDA filing has been accepted under priority review for relapsing and primary progressive multiple sclerosis. The application draws on the FENhance 1, FENhance 2 and FENtrepid Phase III studies.
Roche’s collaborator MediLink reported phase III TAISHAN-302 data showing Tam-Peli (tambotatug pelitecan) reduced the risk of death by 54% versus topotecan in Chinese patients with relapsed small-cell lung cancer, meeting its primary endpoint with a favorable safety profile.
The FDA has granted Priority Review to Roche’s Enspryng (satralizumab) for MOGAD, a rare autoimmune CNS disease with no approved treatments, after Phase III METEOROID data showed a 68% relapse risk reduction.
New two-year data from Roche’s Phase IIIb/IV SALWEEN trial show that Vabysmo (faricimab) delivers durable vision gains and disease control in Asian patients with polypoidal choroidal vasculopathy (PCV), a severe subtype of neovascular age-related macular degeneration, while cutting treatment visits for the majority of patients.
Genentech, Roche’s US subsidiary, will invest approximately $750 million to build a new device fill-finish facility at its Hillsboro, Oregon campus, adding 250 manufacturing jobs and doubling the site’s size ahead of a 2031 commercial start.
Genentech and Roche have filed a new patent-infringement lawsuit against Biocon in New Jersey federal court, alleging Biocon’s proposed pertuzumab biosimilar infringes patents covering Perjeta, Roche’s blockbuster HER2-positive breast-cancer treatment, the second major U.S. action against Biocon over the same product in 2026.
Roche’s next-generation KRAS G12C inhibitor, divarasib, has achieved statistical significance in a global head-to-head Phase III trial against sotorasib and adagrasib for advanced non-small cell lung cancer.
Roche has officially announced the launch of AXELIOS 1, a next-generation sequencing platform built on proprietary SBX technology, promising same-day whole-genome sequencing with unprecedented speed and accuracy.
Roche announces FDA Priority Review for giredestrant, the first oral SERD showing positive phase III results in the curative, adjuvant setting for ER-positive early breast cancer.
