Tags : US FDA Approval

Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the

Shots: The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe […]Read More

BioMarin Receives the US FDA’s Approval Allowing Maximum Dose of

Shots: The US FDA has approved the sBLA to increase the maximum allowable dose of 60mg with Palynziq for PKU. Previously, the maximum dose was 40mg The label expansion is based on OLE study out to 3yrs. demonstrating that 66% had a blood Phe level ≤360 μmol/L consistent with the Phe target ACMG recommended guidelines […]Read More

RadioMedix and Curium Detectnet (copper Cu 64 dotatate injection) Receives

Shots: The approval is based on P-lll study which involves assessing Detectnet (copper Cu 64 dotatate injection) in Neuroendocrine Tumors (NETs) patients. Curium expects to launch detectnet immediately with doses available through various nuclear pharmacies The P-III results demonstrated that the clinical sensitivity and specificity provide great aid to clinicians to develop an accurate treatment […]Read More