Shots: Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized […]readmore
Tags : Regulatory
Shots: Egle has achieved the first milestone in its research agreement with Takeda, signed in June’2020. Egle will validate novel tumor-infiltrating regulatory T-cell targets while Takeda will develop the potential […]readmore
Shots: The P-I dose-escalation study will assess the safety, tolerability, and preliminary efficacy of DS-1055 in adult patients with r/r advanced or metastatic head and neck, gastric and esophageal cancers, […]readmore
The DIA India Medical Devices Conference 2020 is the first effort of DIA India to bring together leaders from the medical devices industry, regulatory and academia from India in New […]readmore
The Medical Devices Conference will be hosted by DIA India on 21st and 22nd February in collaboration with Medical Technology Association of India (MTaI), AIC-AMTZ Medivalley Incubation Council and mDI […]readmore
The Medical Devices Conference hosted by DIA India on 21st and 22nd February in collaboration with Medical Technology Association of India (MTaI), AIC-AMTZ Medivalley Incubation Council and mDI Europa, is […]readmore
Shots: The approval is based on two P-III studies assessing Orilissa 150 mg qd and 200 mg bid vs PBO enrolling 1,700 women with moderate to severe endometriosis pain P-III […]readmore
Shots: The NDA and MAA Acceptance of Siponimod is based on P-III EXPAND study, assessing Siponimod vs PBO in adults with Secondary Progression Multiple Sclerosis (SPMS) evaluating its safety and […]readmore
Shots: The Notice of Compliance (NOC) authorization is based on the clinical trial assessing Radicava (edaravone), demonstrating its positive 1EP measured by using the ALSFRS-R Edaravone is a IV medication, […]readmore
Shots: The approval is based on the results of P-II EMPOWER-CSCC-1 study and P-I study 1423 (two advanced CSCC expansion cohorts) assessing Libtayo in patients with mCSCC, locally advanced CSCC […]readmore