The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction
The company recently raised US $ 2.25 million seed round and the app was CE-Certified as a medical device in Europe
This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease
These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke
Nucala is the first and only monthly biologic in the EU evaluated in a wide COPD population with an eosinophilic phenotype
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
The PRIOH-1 study met its primary endpoint, delivering statistically significant and clinically meaningful improvements in lesion healing
Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
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