Shots: The application is based on P-Ib/II CARTITUDE-1 study evaluating cilta-cel in adults with r/r MM who have received at least 3 prior line therapies across the US, EU, China, […]readmore
Tags : Submission
Shots: The company has submitted MAA for Omburtamab to EMA for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma The company continues to advance the Omburtamab program addressing […]readmore
Shots: The submission is based on P-IIb/III SELECTION study evaluating the efficacy and safety of filgotinib (200mg, qd) vs PBO in patients with mod. to sev. active UC who had […]readmore
Shots: The sBLA is based on data from the P- I/II ZUMA-3 trial in adult patients age ≥18 years old for the treatment of adult patients with r/r B-cell ALL […]readmore
Shots: The NDA submission is based on data from P-III PROTECTIVE-2 study evaluating Plinabulin + Neulasta vs Neulasta alone for the prevention of CIN The study met its 1EPs and […]readmore
Shots: The NDA is based on the P-III EASE trial involves assessing Oleogel-S10 (filsuvez) vs control gel in patients with EB. The study met its 1EPs of accelerated healing of […]readmore
Shots: The EUA submission is based on an interim analysis of the P-III COMET-ICE study assessing VIR-7831 vs PBO for the early treatment of COVID-19 in 583 adults at high […]readmore
Shots: The submission is based on P-III HELP study evaluating lanadelumab (300mg, q2w & q4w) vs PBO in 125 patients with HAE attack for 26wks. It also based on P-III […]readmore
Shots: The submission is based on EV-301 and EV-201 trials in Japan. The P-III EV-301 trial assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with […]readmore
Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of […]readmore