Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
The U.S. FDA issued a Form 483 with five observations
Now integrates with Abbott’s instinct sensor and approved for type 2 diabetes
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations
The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
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