Shots: The approval is based on P-III ORIENT-32 study involves assessing efficacy and safety of Tyvyt + bevacizumab vs sorafenib in 571 patients in a ratio (2:1) as a 1L […]readmore
Shots: The conditional approval is based on results from a P-II trial in China evaluating the safety & efficacy of Brukinsa in patients with WM who have received at least […]readmore
Shots: The approval is based on P-III ORIENT-12 trial evaluating Tyvyt (sintilimab injection) or PBO + Gemzar (gemcitabine) & platinum CT in 357 patients in a ratio (1:1) as 1L […]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 NMPA has approved Lee pharma to initiate P-III clinical trials to evaluate Socazolimab + CT as a 1L treatment of ES-SCLC. The study is expected to initiate patient […]readmore
Shots: NMPA has granted BTD to socazolimab for cervical cancer. Socazolimab is licensed from Sorrento to COF for the greater China territory Lee intends to file an NDA to the […]readmore
Shots: The approval is based on P-III DAPA-HF trial involves assessing of Forxiga (10mg, qd) + SOC (ACEi or ARB) vs PBO + SOC in 4,744 patients with HFrEF (LVEF […]readmore
Shots: The approval was based on P-III ADMIRAL assessing gilteritinib (120mg, qd) vs CT in 319 patients with relapsed or refractory AML. The study showed patients had significantly longer overall […]readmore
Shots: The approval follows P-III ORIENT-11 study assessing Tyvyt (sintilimab) vs PBO + Almita (pemetrexed) and platinum CT in 397 participants in a ratio (2:1) as 1L therapy for advanced […]readmore
Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one […]readmore
Copyright © 2020 Digiqole. All Right Reserved.