Shots: The NMPA has approved a P-I/II SWATCH dose-escalation & dose-expansion study that evaluates the safety, tolerability, and preliminary efficacy of selinexor in combination with the R2 regimen of lenalidomide […]readmore
Tags : approval
Shots: The approval is based on the P-III KEYNOTE-564 trial evaluating Keytruda (200mg, IV, q3w for 1yrs.) vs PBO in a ratio (1:1) in 994 patients with intermediate-high or high […]readmore
Shots: The approvals are based on the clinical trials to evaluate mepolizumab vs PBO when added to SoC in patients with HES, EGPA & CRSwNP In HES, patients experienced a […]readmore
Shots: The approval is based on the data from PK bridging studies and P-III EVOLVE-MS-2 study to evaluate the GI tolerability of Vumerity vs Tecfidera in patients with relapsing-remitting MS […]readmore
Shots: The EC has granted marketing authorisation for Celltrion’s regdanvimab in adults with COVID-19 who do not require supplemental oxygen & are at high risk of progressing to severe COVID-19 […]readmore
Shots: The EMA’s CHMP has adopted a positive opinion recommending the marketing authorization for Wegovy in adults with obesity in chronic weight management in adults with obesity The approval is […]readmore
Shots: The NMPA has approved an IND application for P-Ib MATCH, dose-escalation study to evaluate the safety of ATG-008 + ATG-010 in patients with r/r DLBCL. The study will be […]readmore
Shots: The approval is based on the P-III GEMINI 1 & 2 studies to evaluate the efficacy, safety, and tolerability of Vuity vs PBO in a ratio (1:1) in 750 […]readmore
Shots: Health Canada has granted a NOC based on the P-II ZUMA-2 trial that evaluates Tecartus in 74 adult patients with r/r MCL who had previously received anthracycline or bendamustine […]readmore
Shots: The approval is based on the P-III PEACHTREE trial to evaluate Xipere in 160 patients with macular edema associated with uveitis. The therapy is expected to be available in […]readmore