Browsing Tag
Roche Holding AG
15 posts
Roche gets January FDA date for Enspryng after cutting MOGAD relapse risk 68%
Roche has secured FDA Priority Review for Enspryng in MOGAD after Phase 3 data showed a 68% reduction in relapse risk, with a U.S. decision due by January 10, 2027.
Elecsys pTau217 wins FDA clearance as Roche pushes Alzheimer’s testing into primary care
Roche has secured FDA clearance for Elecsys pTau217, giving more than 4,500 existing U.S. cobas analyzers a potential role in assessing Alzheimer’s amyloid pathology through a routine blood draw.
Otsuka’s Astex signs $490m-plus Genentech breast cancer partnership
Astex signs a $490 million-plus Genentech breast cancer deal. Discover how Otsuka’s fragment platform could reshape Roche oncology research and returns.
Genentech secures first ctDNA MRD-guided therapy approval for Tecentriq in MIBC
A cancer drug win is only half the story. Roche and Natera are testing whether ctDNA can decide who truly needs treatment.
Roche’s Columvi shows durable three-year overall survival edge over Rituxan in phase III STARGLO trial
Find out how Roche’s Columvi delivered a durable three-year survival advantage in the phase III STARGLO lymphoma trial and what it means for patients and investors.
Roche secures FDA clearance and CE Mark for rapid pertussis point-of-care diagnostic test
Discover how Roche’s FDA-cleared rapid pertussis test could transform point-of-care diagnosis and reshape decentralized molecular diagnostics worldwide.
Can Roche’s 62% success rate in breast cancer trials spark the next oncology breakthrough?
Roche’s new oral breast-cancer therapy cut disease-progression risk by up to 62% in late-stage trials. Find out how it could reshape treatment in 2025.
The fibrosis frontier: Can anti-fibrotic drugs finally deliver where weight-loss therapies fall short?
Can anti-fibrotic drugs succeed where weight-loss therapies have stalled? Explore the future of MASH treatment and why fibrosis is the key clinical frontier.
89bio stock soars 85% as Roche seals $3.5bn takeover—What’s behind the surge and what’s next?
Roche is buying 89bio for up to $3.5B to add Phase 3 MASH drug pegozafermin. Find out what the CVR means and how investors should read the deal today.
Eisai’s etalanetug earns FDA Fast Track status, signaling new hope in Alzheimer’s therapy
Eisai’s etalanetug gets FDA Fast Track for Alzheimer’s, signaling a major shift toward tau-targeting therapies. Find out what this means for investors.