Shots: The approval is based on results from the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete […]readmore
Tags : approval
Shots: The US FDA has approved the sBLA for a new self-administration option for Xolair in patients across all approved indications in the US The use of the therapy across […]readmore
Shots: The EC has approved MB02 biosimilar to Avastin (Bevacizumab) in the EU for the treatment of carcinoma of the colon or rectum, BC, NSCLC, RCC, epithelial ovarian, fallopian tube […]readmore
Shots: The approval is based on the P-III study that involves assessing Taltz (20mg for <25kg/40mg for 25-50kg/80 mg for >50 kg @12wks., with 40/80/160mg starting doses, respectively) vs PBO […]readmore
Shots: The approval is based on data from an extensive development program that consists of four P-III clinical trials evaluating Qelbree in 1000+ pediatric patients aged 6 to 17 yrs. […]readmore
Shots: The approval is based on P-III IKEMA study involves assessing of Sarclisa + carfilzomib and dexamethasone(kd) vs SOC in 302 patients with RRMM who had received 1 to 3 […]readmore
Shots: The US FDA has approved Roszet for the treatment of elevated LDL-C in adult patients with primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia The result showed a reduction of […]readmore
Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Cabometyx + Opdivo vs sunitinib in 651 patients with previously untreated advanced/m-RCC The results demonstrated significant improvement across […]readmore
Shots: In an interview with PharmaShots, Dr. Ahmet Sezer, Sanofi’s Peter C. Adamson, and Regeneron’s Israel Lowy shared their views on the US FDA’s approval of Libtayo and the data […]readmore
Shots: The approval is based on P-III ASCLEPIOS I and II studies that involve assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, PO, qd) in 1,882 adults aged 18-55yrs. with […]readmore