Shots: The BTD is based on P-II CITYSCAPE study assessing Tiragolumab + Tecentriq vs Tecentriq + PBO as a 1L treatment of 135 patients in a ratio (1:1) with LA […]readmore
Tags : US FDA’s
Shots: The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review […]readmore
Shots: The US FDA has granted orphan drug designation for AP103 for the treatment of DEB Amyrt licensed a pre-clinical gene – therapy platform technology to treat patients with DEB, […]readmore
Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in patients with advanced NSCLC with KRAS G12C mutation whose cancer had progressed despite prior treatment with […]readmore
Shots: The US FDA’s EUA follows the launch of the Elecsys Anti-SARS-CoV-2 S Ab test for markets accepting the CE Mark. The serology test can be used to measure the […]readmore
Shots: The US FDA has approved Danyelza (40mg/10ml) and is indicated in combination with GM-CSF for pediatric patients aged 1yrs. & older and adult patients with r/r high-risk neuroblastoma in […]readmore
Shots: The US FDA has issued a EUA for casirivimab (1,200mg) + imdevimab (1,200mg) administered together for mild to mod. COVID-19 in adults and pediatric patients aged ≥12yrs. weighing at […]readmore
Shots: The FDA has approved Imfinzi for an additional dosing option (1500mg, FD, q4w) in the approved indications of unresectable stage III NSCLC after CRT and prior treated advanced bladder […]readmore
Shots: The US FDA has granted FT designation to NVX-CoV2373 which is currently in late-phase clinical development. Novavax expects to initiate pivotal P-III study in the US & Mexico by […]readmore