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
Tags : FDA
The US FDA has approved 4 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and […]readmore
Shots: The designation is based on the results of the P-III JUPITER-06 clinical trial that evaluates toripalimab + CT vs CT alone in patients with advanced or metastatic ESCC The […]readmore
Shots: The sNDA is based on P-III EMPEROR-Preserved trial evaluates the safety and efficacy of Jardiance (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes The results […]readmore
Shots: The NDA is based on CENTAUR trial evaluates AMX0035 vs PBO in 137 patients with ALS The results showed that patients receiving AMX0035 had a significant functional decline at […]readmore
Shots: The US FDA has accepted the BLA for toripalimab + CT (gemcitabine & cisplatin) & toripalimab as monothx. to treat advanced recurrent or metastatic NPC after platinum-containing CT. The […]readmore
Shots: The submission is based on P-II studies i.e., CITADEL-203/204/205 that evaluate parsaclisib in patients with r/r FL, MZL & MCL. The anticipated PDUFA date for parsaclisib in adult patients […]readmore
Shots: The company will initiate the P-I/II dose-escalation & expansion study to evaluate the safety, PK & anti-tumor activities of IMP9064 as monothx. & in combination with Senaparib in patients […]readmore
Shots: The submissions are based on the P-II ELARA trial evaluates the efficacy and safety of Kymriah in adult patients with r/r FL after at least two prior therapies over […]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