FDA completes inspection at Biocon Biologics' facility in Bengaluru
The U.S. FDA issued a Form 483 with five observations
The U.S. FDA issued a Form 483 with five observations
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
The trial is the largest to date evaluating Leqvio and the first to focus on patient-centered outcomes
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
Glenmark’s Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Halaven Injection, 1 mg/2 mL (0.5 mg/mL),of Eisai
Enters the high growth vitamins, minerals and supplements segment for adults, paediatrics, and animal health
This PSD-3, the first pharmaceutical spray dryer built by GEA for OEB-5 products, sets new standards for high-containment pharmaceutical spray drying
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
The study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users
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