Shots: The expanded approval is based on PREMIER Trial assessing Pipeline Flex in 141 patients with mean aneurysm size of 5.0±1.92 mm The study resulted in one-year occlusion rates of […]readmore
Shots: The FDA’s ODD for Fasenra follows its evaluation in P-II study assessing Fasenra vs PBO @12 weeks in patients with high level of eosinophils in blood and tissues The […]readmore
Shots: The approval is based on P-III HERCULES study results assessing Cablivi + plasma exchange and immunosuppressive therapy vs PBO (plasma exchange and immunosuppressive therapy) in 145 adults with aTTP […]readmore
Shots: The FDA’s BT & EMA’s PRIME designation is based on P-IIb trial results assessing MEDI8897 in patients with LTRI caused by respiratory syncytial virus (RSV) in premature infants @150 […]readmore
Shots: The FDA’s ODD to BL-8040 is granted for pancreatic cancer, with an addition to previously granted for AML and stem-cell mobilization in 2015 The US FDA’s ODD is granted […]readmore
Shots: The positive opinion is based on P-III KEYNOTE-407 trials results assessing Keytruda + CT (carboplatin/paclitaxel/nab-paclitaxel) vs CT monothx. in patients with msq NSCLC The P-III KEYNOTE-407 trials resulted in […]readmore
Shots: The approval is based on the P-II JULIET (NCT02445248) trial results assessing Kymriah (tisagenlecleucel) in patients with 1L+ DLBCL and followed by NICE approval in for pediatric and aged […]readmore
Shots: The approval is based on four P-III trials including two (EV-001 & EV-002) US trials and European & Canadian i.e TRANSPARENCY study results assessing Jeuveau vs PBO & Botox […]readmore
Shots: The expanded label approval is based on P-III KEYNOTE-189 study results assessing Alimta + pembrolizumab + Pt-based CT vs Alimta + Pt-based CT +PBO in 616 patients with mnon-sq […]readmore
Shots: The BT designation is based on P-I/II and P-II results assessing four lots of V114 in healthy adults and infants, demonstrating non-inferiority data in patients FDA’s BT designation is […]readmore
Copyright © 2020 Digiqole. All Right Reserved.