Shots: The approvals are based on the clinical trials to evaluate mepolizumab vs PBO when added to SoC in patients with HES, EGPA & CRSwNP In HES, patients experienced a […]readmore
Tags : EC
Shots: The approval is based on the data from PK bridging studies and P-III EVOLVE-MS-2 study to evaluate the GI tolerability of Vumerity vs Tecfidera in patients with relapsing-remitting MS […]readmore
Shots: The EC has granted marketing authorisation for Celltrion’s regdanvimab in adults with COVID-19 who do not require supplemental oxygen & are at high risk of progressing to severe COVID-19 […]readmore
Shots: The approval is based on the P-III trial that evaluates Ultomiris (q4w/q8w) vs Soliris in children & adolescents aged ≤18yrs. with PNH The interim result showed that the therapy […]readmore
Shots: The conditional approval is based on the P-II L-MIND study evaluating the safety and efficacy of tafasitamab + lenalidomide in patients with r/r DLBCL who are not eligible for […]readmore
Shots: The approval is based on 3 P-III studies i.e., Measure Up 1/2/AD Up evaluating the efficacy & safety of Rinvoq (15/30 mg, qd) as monothx. with TCS vs PBO […]readmore
Shots: The approval is based on 3 P-III studies i.e., BE VIVID, BE READY, BE SURE evaluating the efficacy & safety of bimekizumab vs PBO + ustekinumab, PBO, adalimumab in […]readmore
Biosimilars
Regulatory
Samsung Bioepis’ Byooviz (biosimilar, ranibizumab) Receives EC’s Approval for the
Shots: The EC has approved Byooviz (biosimilar, ranibizumab) in the EU for the treatment of Ophthalmic disease Lucentis is used to treat ophthalmic disease & macular degeneration. Byooviz marks the […]readmore
Shots: The conditional approval is based on KarMMa study evaluating Abecma (single infusion with a target dose of 420 x 10^6 CAR T cells over a range of 260 to […]readmore
Shots: The approval is based on safety & efficacy data from the P-III LIBERTY program that consists of 2 studies i.e LIBERTY 1 & 2 evaluating Ryeqo in adult women […]readmore