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Agios Continues Collaboration With FDA To Finalize Mitapivat sNDA Documentation For Thalassemia Treatment
Agios says FDA has not yet issued a final decision on mitapivat sNDA for alpha and beta thalassemia as labeling and REMS review continues.
Vaibhavi M.
Roche’s Three-Year STARGLO Data Confirm Long-Term Survival Advantage Of Columvi + GemOx In R/R DLBCL; Sustains Strong Efficacy And Safety, Reinforcing Global Adoption
Roche reports 3-year STARGLO data showing Columvi plus GemOx doubled overall survival in relapsed or refractory DLBCL patients.
Vaibhavi M.
Praxis Reports Strong EMBOLD And RADIANT Results, Highlighting Rapid And Durable Seizure Reduction Across Programs
Praxis reports positive EMBOLD data for relutrigine, showing strong seizure reduction and favorable safety, and plans FDA meeting for potential NDA.
Vaibhavi M.
Roche Secures European Commission Approval For Obinutuzumab Combo Therapy, Marking A Major Advancement In Lupus Nephritis Treatment
Roche receives EU approval for Gazyva/Gazyvaro with MMF in active lupus nephritis, offering a new treatment option to slow kidney damage.
Vaibhavi M.
