Palvella Therapeutics completes its QTORIN FDA submission after positive Phase 3 results, moving a potential first microcystic LM therapy closer to approval.
Milvexian failed to reduce cardiovascular death, heart attack or ischemic stroke after acute coronary syndrome in the Phase 3 LIBREXIA ACS trial, although the drug did not increase intracranial or fatal bleeding, leaving two major Phase 3 programs to determine whether factor XIa inhibition still works in other diseases.
The landmark STAREE randomized trial found that atorvastatin reduced first major cardiovascular events by 30% among adults aged 70 and older without established cardiovascular disease, diabetes or dementia, potentially resolving a long-running treatment question for older patients.
Revolution Medicines has secured FDA approval for Rasonque, or daraxonrasib, after a 500-patient Phase 3 trial showed median survival of 13.2 months compared with 6.7 months on chemotherapy in previously treated metastatic pancreatic cancer.
The FDA has approved Eli Lilly and Company’s Mounjaro to reduce cardiovascular death, heart attack and stroke risk in high-risk adults with type 2 diabetes, significantly broadening the clinical case for tirzepatide beyond glucose control and weight reduction.
The U.S. Food and Drug Administration has approved once-weekly MIMRYLO, or rusfertide, for erythrocytosis in adults with polycythemia vera, introducing the first therapy designed to mimic the iron-regulating hormone hepcidin.
Tenax Therapeutics has presented a deeper analysis of its Phase 3 LEVEL trial showing substantially stronger TNX-103 effects in PH-HFpEF patients with poorer baseline exercise capacity, giving the company a potential enrichment strategy for its ongoing LEVEL-2 registrational program despite LEVEL missing its primary endpoint.
Amgen and AstraZeneca say TEZSPIRE achieved both co-primary and all key secondary endpoints in the Phase 3 CROSSING study, potentially extending the TSLP-blocking biologic into eosinophilic esophagitis.
Genentech has entered a global collaboration with DualityBio to develop antibody-drug conjugates using novel payloads designed to address tumors resistant to widely used topoisomerase inhibitor ADCs.
CTX310 sustains deep ANGPTL3, LDL and triglyceride reductions for one year after one infusion. See what the data mean for CRISPR Therapeutics.