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Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for Investigational Treatment for NASH


Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for Investigational Treatment for NASH
FDA s Fast Track Designation for the GLP-1/glucagon dual agonist underscores the urgent need for new treatment options to fulfill the unmet medical needs of people affected by NASH.
Boehringer Ingelheim s focus on the development of next generation NASH treatments builds on its strong track record of bringing new therapies to people with cardiometabolic diseases.
Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078) today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the GLP-1/glucagon dual agonist BI 456906 for adults with non-alcoholic steatohepatitis (NASH). The Fast Track Designation facilitates the development and expedites the review of new therapies to treat serious conditions and fill an unmet medical need. BI 456906 is currently being evaluated in a Phase II study in adults wi ....

David Rosen , Birgit Leimer , Waheed Jamal , Claudia Styslinger , Adam Steensberg , Zealand Pharma , Product Communications , Boehringer Ingelheim Corporate Center Gmb , Boehringer Ingelheim , Drug Administration , Track Designation , Fast Track Designation , Corporate Vice President , Cardiometabolic Medicine , Executive Vice President , Chief Medical Officer , Communications Manager , Ingelheim Corporate Center Gmbh , டேவிட் ரோஸன் , வீத் ஜமால் , ஜீலாந்து பார்மா , ப்ராடக்ட் தகவல்தொடர்புகள் , போஹெரிங்கர் இஂகல்‌ஹைம் பெருநிறுவன மையம் க்ம்ப் , போஹெரிங்கர் இஂகல்‌ஹைம் , டிராக் பதவி , வேகமாக டிராக் பதவி ,

Redirecting to CHMP issues positive opinion for Jardiance® (empagliflozin) for the treatment of adults with heart failure with reduced ejection fraction


May 21, 2021 healthcare
CHMP issues positive opinion for Jardiance® (empagliflozin) for the treatment of adults with heart failure with reduced ejection fraction
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance® (empagliflozin) for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company announced.1
“Heart failure is a progressive and debilitating condition affecting 60 million people worldwide.2 It is the leading cause of hospitalizations in Europe – not only impacting the quality of life considerably for those living with the condition but also putting significant pressure on healthcare systems,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. � ....

Faiez Zannad , Waheed Jamal , Eli Lilly , Jeff Emmick , Product Development , University Of Lorraine , European Medicines Agency , European Commission , Boehringer Ingelheim , Committee For Medicinal Products Human Use , Medicinal Products , Human Use , Emeritus Professor , Marketing Authorisation , Corporate Vice President , Cardiometabolic Medicine , Vice President , Failure Studies , வீத் ஜமால் , எலி லில்லி , ஜெஃப் எம்மிக்க் , ப்ராடக்ட் வளர்ச்சி , பல்கலைக்கழகம் ஆஃப் லோரெய்ன் , ஐரோப்பிய தரகு , போஹெரிங்கர் இஂகல்‌ஹைம் , குழு க்கு மருத்துவ ப்ராடக்ட்ஸ் மனிதன் பயன்பாடு ,