Shots: The EMA’s CHMP has adopted a positive opinion recommending the conditional marketing authorization for Lumykras to treat advanced NSCLC with KRAS G12C mutation & who have progressed after 1 […]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 EMA’s CHMP has issued a positive opinion recommending the marketing authorization for regdanvimab (CT-P59) in adults with COVID-19 who do not require supplemental oxygen & are at increased […]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 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 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 approval is based on P-III ASCEMBL & P-I study that evaluates Scemblix in patients with Ph+ CML-CP with T315I mutation who had experienced resistance or intolerance to two […]readmore
Shots: The MAA is based on the P-II LOTIS-2 study evaluating Zynlonta (CD19-directed ADC) in 145 patients with r/r DLBCL following two or more prior lines of systemic therapy The […]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