Shots: NICE has issued a positive Final Appraisal Document which recommends Sunosi (75/150mg, qd) as an option treatment for adults with EDS caused by narcolepsy with/out cataplexy. The therapy will […]readmore
Shots: The NMPA has approved a P-I/II SWATCH dose-escalation & dose-expansion study that evaluates the safety, tolerability, and preliminary efficacy of selinexor in combination with the R2 regimen of lenalidomide […]readmore
Shots: The approval is based on the P-III KEYNOTE-564 trial evaluating Keytruda (200mg, IV, q3w for 1yrs.) vs PBO in a ratio (1:1) in 994 patients with intermediate-high or high […]readmore
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
Shots: The designation is based on the ongoing P-III DIALIZE-Outcomes trial to evaluate the effect of Lokelma on arrhythmia-related CV outcomes in patients with chronic hemodialysis with recurrent HK at […]readmore
Shots: The approval is based on KEEPsAKE-1 & 2 studies to evaluate Skyrizi (150mg) vs PBO in patients with active PsA who had an inadequate response or were intolerant to […]readmore
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 designation is based on the results of the P-III JUPITER-06 clinical trial that evaluates toripalimab + CT vs CT alone in patients with advanced or metastatic ESCC The […]readmore
Vertex’s Kaftrio (ivacaftor/tezacaftor/elexacaftor) + Ivacaftor Receives CHMP’s Positive Opinion for
Shots: The EMA’s CHMP has adopted a positive opinion for the label extension of Kaftrio in combination with ivacaftor to treat CF in patients aged 6 to11 yrs. who have […]readmore