Shots: The approval is based on P-III ENVISION I study that involves assessing the efficacy, safety, and PK of Humira (SC) in pediatric patients aged 4-17yrs. with mod. to sev. […]readmore
Tags : approval
Shots: The US FDA has approved the BLA filing for Jemperli for adult patients with dMMR recurrent or advanced solid tumors endometrial cancer, as determined by an FDA-approved test, that […]readmore
Shots: The US FDA has approved Ventana MMR RxDx panel to identify endometrial cancer patients who are eligible for treatment with GSK’s Jemperli (monothx.) that has received the US FDA’s […]readmore
Shots: The US FDA has approved Pipeline Flex Embolization Device with a Shield Technology to advance flow diversion therapy that demonstrates a reduction in material thrombogenicity or a reduction in […]readmore
Shots: The approval is based on P-III study evaluating cannabidiol (25 mg/kg/day) vs PBO in patients aged ≥2yrs. as an adjunctive treatment of seizures associated with TSC The study met […]readmore
Regulatory
Janssen’s Darzalex (daratumumab, SC) Combination Regimen Receives Health Canada’s Approval
Shots: The approval is based on results from the P-III ANDROMEDA (AMY3001) study involves assessing the safety and efficacy of Darzalex (1800mg, SC, qw) + bortezomib, cyclophosphamide, and dexamethasone (VCd) […]readmore
Shots: The approval is based on data from the P-III IKEMA study evaluating Sarclisa + carfilzomib and dexamethasone (Kd) vs Kd alone in 302 patients with relapsed MM across 69 […]readmore
Shots: The FDA has approved Nextstellis (3 mg, DRSP, and 14.2 mg, E4 tablets) for the prevention of pregnancy and is expected to be commercially available in Jun’2021 The P-III […]readmore
Shots: The approval is based on two studies i.e. FIREFISH & SUNFISH. The FIREFISH study involves assessing Evrysdi in infants aged 2-7mos. with symptomatic Type 1 SMA, and the SUNFISH […]readmore
Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC Results: @median follow-up […]readmore