Shots: The sNDA application is based on P-III CAPSTONE-2 assessing Xofluza vs placebo & oseltamivir (75 mg) in 2,184 patients with high risk of complications from the influenza including asthma, […]readmore
Tags : Acceptance
Shots: The NDA filing is based on the P-III RESTORE-IMI 1 study results, assessing Imipenem/Cilastatin + Relebactam (IMI/REL) vs imipenem/cilastatin + colistin (IMI+CST) in patients with gram-negative bacterial infections The […]readmore
Biosimilars
Biotech
Innovent Biologics Reports Acceptance of BLA for IBI-305 (bevacizumab, biosimilar)
Shots: The BLA is based on two P-III study results assessing efficacy, safety and PK of IBI-305 vs bevacizumab in patients with advanced non-sq NSCLC and has demonstrated in meeting […]readmore
Shots: The filling is based on the results of P-III IMpassion130 study, assessing Tecentriq + Abraxane vs PBO + Abraxane in 902 patients with 1L unresectable LA/M TNBC in ratio […]readmore
Shots: The filling is based on results of P-III SOLO-1 study assessing Lynparza (300mg bid) vs PBO as a monothx in 391 newly-diagnosed patients with BRCA-m advanced ovarian cancer in […]readmore
Shots: The sNDA application is based on results of P-III iLLUMINATE (PCYC-1130) trial assessing Imbruvica (420) + Obinutuzumab (1000) vs chlorambucil (Days 1 & 15) + obinutuzumab (1000) over 6 […]readmore
Shots: The NDA and MAA Acceptance of Siponimod is based on P-III EXPAND study, assessing Siponimod vs PBO in adults with Secondary Progression Multiple Sclerosis (SPMS) evaluating its safety and […]readmore
Shots: Results of P-III ODYSSEY OUTCOMES assessing PRALUENT(alirocumab) IV (N= 18,924), having an acute coronary syndrome (ACS), such as a heart attack, b/w 1-12 mos before being enrolled The US […]readmore