regulatory submission
Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx PCR Platform to Support Submission to the U.S. FDA
Co-Diagnostics; clinical evaluations; multiplex test; point-of-care; Co-Dx PCR Platform; FDA 510(k); Flu A/B; COVID-19; RSV; regulatory submission
Lilly’s Oral GLP-1, Orforglipron, Achieves Two New Clinical Wins in Type 2 Diabetes
Lilly; Orforglipron; oral GLP-1; type 2 diabetes; clinical trial; weight loss; regulatory submission; ACHIEVE-1; ATTAIN-2; semaglutide; Farxiga; efficacy; safety
Regeneron Reports Phase 3 Success for Cemdisiran in Rare Disease Generalized Myasthenia Gravis
Regeneron; Phase 3 trial; cemdisiran; generalized myasthenia gravis; rare disease; RNA drug; siRNA; Alnylam Pharmaceuticals; U.S. regulatory submission
Akeso Scores Two Wins in Phase 3 Trials, Tees Up Regulatory Submissions in China
Akeso; Phase 3 trials; gumokimab; manfidokimab; ankylosing spondylitis; atopic dermatitis; regulatory submission; China; autoimmune diseases; clinical trial results
Lilly’s Q2 2025 Beat-and-Raise Overshadowed by Orforglipron Data
Eli Lilly; Q2 2025 earnings; orforglipron; oral GLP-1; weight loss; obesity franchise; regulatory submission; analyst expectations