Shots: The expanded indication approval is based on the results of P-III FOURIER study assessing Repatha (140mg q2w, 420 mg/month) vs PBO + statin therapy in patients with cardiovascular events […]readmore
Tags : NMPA
Shots: The approval is based on P-III study results assessing Linzess (290 mcg) vs PBO in 839 patients in ratio the (1:1) with IBS-C in adults for 12 weeks The […]readmore
Shots: The approval is based on ORIENT-1 study results assessing Tyvyt in patients with 2L+ Hodgkin’s lymphoma The ORIENT-1 study resulted in effective complete response rates for CT + radiotherapy in patients […]readmore
Shots: The approval is based on three P-III study (104,111 & 109) results assessing Genvoya (elvitegravir/ cobicistat /emtricitabine /tenofovir alafenamide /150 / 150/ 200/ 10mg, E/C/F/TAF) vs Stribild (E/C/F/TDF,150 mg/ […]readmore
Shots: The approval is based on the results of two international P-III 108 and 110 study assessing Vemlidy vs Viread in 1,632 patients with HBeAg-negative and HBeAg-positive HBV disease for […]readmore