Tags : approval

Regulatory

Althera’s Roszet (rosuvastatin and ezetimibe) Receives the US FDA’s Approval

Shots: The US FDA has approved Roszet for the treatment of elevated LDL-C in adult patients with primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia The result showed a reduction of LDL cholesterol by 72% with 40mg/10mg dose and 64% with 10 mg/10mg dose. The level of LDL-reduction indicates from both the statin component i.e rosuvastatin […]Read More

Regulatory

Ipsen’s Cabometyx + Opdivo Receive EC’s Approval as a 1L

Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Cabometyx + Opdivo vs sunitinib in 651 patients with previously untreated advanced/m-RCC The results demonstrated significant improvement across all efficacy EPs. The trial met its 1EPs i.e. showed doubled mPFS (16.6 vs 8.3mos.); ORR (55.7% vs. 27.1%); CR (8.0% vs 4.6%); OS (40% […]Read More