Shots: The ODD designation follows P-I/II SPRINT Stratum 1 study assessing Selumetinib (bid) as monothx. in pediatric patients with NF1-related inoperable PNs The P-I/II SPRINT Stratum 1 study demonstrated a […]readmore
Tags : MHLW
Biotech
Regulatory
Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum
Shots: The approval is based on two P-III SAkuraStar & SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx & as an add-on therapy to baseline IST vs […]readmore
Shots: The five therapies include Tabrecta (capmatinib) for advanced and recurrent unresectable NSCLC, Entresto (sacubitril valsartan sodium hydrate) for chronic HF, Mayzent (siponimod fumaric acid) for secondary PMS, Enerzair (glycopyrronium […]readmore
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it The outbreak of the respiratory disease was first detected […]readmore
Shots: The MAA is submission is based on P-I trial of adult patients, P-II NAVIGATE study in adult and adolescent patients and the P-I/II pediatric SCOUT study. These trials evaluate […]readmore
1.Fitbit Launches Heart Study to Validate its Wearable Technology for Identifying Atrial Fibrillation Published: May 06, 2020 | Tags: Fitbit, Launches, Heart Study, Validate, Wearable Technology, Identifying, Atrial Fibrillation 2. […]readmore
Shots: Shots: The approval is based on NIAID led P-III SIMPLE study assessing Veklury in patients with severe manifestations of COVID-19, and available data from Gilead’s compassionate use program including […]readmore
Shots: Shots: Japan will fast-track a review of Gilead’s remdesivir to approve it for COVID-19 patients, following the US FDA’s EUA for the therapy. If approved, Remdesivir would become Japan’s […]readmore
Shots: The MHLW’s approval is based on stand-alone studies in Japan and global clinical programs and is supported by DIALIZE study that demonstrated the efficacy on Lokelma in treating hyperkalemia […]readmore
Shots: The approval is based on ongoing P-II VISION study assessing Tepmetko in 99 patients (including 15 Japanese patients) with NSCLC and METex14 skipping alterations The P-II VISION study […]readmore