Shots: The P-III OA (A4091056) study involves evaluation of Tanezumab (2.5, 2.5/5 mg SC) vs PBO in 698 patients in ratio (1:1:1) with OA of the knee or hip for […]readmore
Tags : patients
Regulatory
Leadiant Biosciences Revcovi’s (elapegademase-lvlr) Receives FDA Approval for Adenosine Deaminase
Shots: The approval is based on two study results assessing Revcovi in patients and demonstrated in an increase in ADA activity, reduction in concentration of toxic metabolites with an improvement […]readmore
Shots: Results: ESTEEM 1, 2: NAPSI@32wk (31.3% vs 15.5), DLQI @16wks. (28.7% vs 8.1%); UNVEIL: NAPSI@32wks. (36.2% vs 37.2%), DLQI@16wks. (23.7% vs 10.6%) Though, Post-hoc analysis revealed that OTEZLA was […]readmore
Shots: The approval is based on P-III DRIVE-FORWARD study assessing Pifeltro (qd) vs darunavir + ritonavir (DRV+r) (800mg, 100 mg, qd) each in combination with emtricitabine (FTC)/TDF or abacavir (ABC)/3TC […]readmore
Shots: The approval is based on two study STICLO France and STICLO Italy assessing Diacomit vs PBO in patients with Dravet Syndrome aged 2 years of age and older taking […]readmore
Shots: The approval is based on five studies assessing Lokelma vs PBO in patients with hyperkalaemia The study resulted in onset of action was at 1.0 hour and the median […]readmore
Shots: The approval is based on CHMP (EMA) recommendation, reviewed by EU for diabetic patients In 2009, Mylan and Biocon globally collaborated to jointly develop multiple generic biologic compounds Semglee […]readmore