Page 3 - லெவி க்யாரவ News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Atezolizumab Gets Priority Review as Adjuvant Treatment for Early NSCLC

Atezolizumab Gets Priority Review as Adjuvant Treatment for Early NSCLC Credit: Getty Images. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for atezolizumab (Tecentriq Â®) as adjuvant treatment following surgery and platinum-based chemotherapy for patients with non-small cell lung cancer (NSCLC) whose tumors express PD-L1 of at least 1%, as determined by an FDA-approved test. The sBLA is supported by data from the global, multicenter, open-label, randomized phase 3 IMpower010 study (ClinicalTrials.gov Identifier: NCT02486718) that compared the efficacy and safety of atezolizumab with best supportive care (BSC) in 1005 adults with Stage IB-IIIA NSCLC after resection and adjuvant chemotherapy. Patients were randomly assigned 1:1 to receive either atezolizumab 1200mg intravenously (IV) every 3 weeks for up to 16 cycles or BSC.Â

Levi garrawayDrug administrationGlobal product developmentPriority reviewBiologics license applicationGlobal productலெவி க்யாரவஉலகளாவிய ப்ராடக்ட் வளர்ச்சிப்ரையாரிடீ விமர்சனம்உயிரியல் உரிமம் விண்ணப்பம்உலகளாவிய ப்ராடக்ட்

Tecentriq wins FDA priority review for certain early NSCLC patients

Tecentriq wins FDA priority review for certain early NSCLC patients
pharmatimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmatimes.com Daily Mail and Mail on Sunday newspapers.

Levi garrawayRoche tecentriqDrug administrationலெவி க்யாரவ

Faricimab Gets Priority Review for Wet AMD, Diabetic Macular Edema

Faricimab Gets Priority Review for Wet AMD, Diabetic Macular Edema Credit: Getty Images The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for faricimab for the treatment of wet, or neovascular, age-related macular degeneration and diabetic macular edema. Faricimab is an investigational bispecific antibody that targets the angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways. Blocking both pathways is expected to stabilize blood vessels and potentially improve vision outcomes in patients with retinal conditions. The BLA is supported by data from two phase 3 trials in patients with wet age-related macular degeneration (TENAYA [ClinicalTrials.gov Identifier: NCT03823287] and LUCERNE [ClinicalTrials.gov Identifier: NCT03823300]) and two phase 3 trials involving patients with diabetic macular edema (YOSEMITE [ClinicalTrials.gov Identifier: NCT03622580] and RHINE [ClinicalTrials.gov Identi

Levi garrawayDrug administrationGlobal product developmentPriority reviewBiologics license applicationGlobal productலெவி க்யாரவஉலகளாவிய ப்ராடக்ட் வளர்ச்சிப்ரையாரிடீ விமர்சனம்உயிரியல் உரிமம் விண்ணப்பம்உலகளாவிய ப்ராடக்ட்

FDA grants Breakthrough Therapy Designation for Venclexta

FDA grants Breakthrough Therapy Designation for Venclexta
selectscience.net - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from selectscience.net Daily Mail and Mail on Sunday newspapers.

Levi garrawayVenclexta venclyxtoRoche groupInternational prognostic scoring systemDrug administrationHead of global product developmentIndustry newsBreakthrough therapy designationChief medical officerGlobal productலெவி க்யாரவரோச் குழுதலை ஆஃப் உலகளாவிய ப்ராடக்ட் வளர்ச்சிதொழில் செய்திதிருப்புமுனை சிகிச்சை பதவிதலைமை மருத்துவ அதிகாரி

Japan becomes first country to approve Ronapreve COVID-19 treatment

Published July 21, 2021, 12:30 PM GENEVA, Switzerland – Swiss pharmaceutical giant Roche said Tuesday that Japan had become the first country to fully approve its Ronapreve antibody treatment for patients with mild to moderate COVID-19. The approval was based on phase 3 trials finding that the antibody cocktail dramatically reduced the likelihood that mild or moderate COVID-19 patients would develop into serious illness causing hospitalization or death. Ronapreve, developed in cooperation with US biotech firm Regeneron, was approved by Japan’s ministry of health, labor and welfare, Roche said in a statement, confirming it was the “first country” to do so. “Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death,” Roche chief medical officer and product development chief Levi Garraway said in a statement.

United statesLevi garrawayEuropean unionEuropean medicines agencyஒன்றுபட்டது மாநிலங்களில்லெவி க்யாரவஐரோப்பிய தொழிற்சங்கம்