Month: February 2023
-
Isolator systems Isolator Validation in pharmaceutical manufacturing technical guide
What is an Isolator in pharmaceutical manufacturing? how to do validation of Pharma Isolator As the name suggests, an isolator is an equipment designed to isolate a drug product during manufacturing from the external environment in the clean room. Isolators separate the drug product from the external environment and protect the drug product from getting…
-
USFD Approved New Drug Leqembi containing lecanemab-irmb for early stage of Alzheimer’s Disease
New drug Leqembi containing lecanemab-irmb for treatment of Alzheimer’s disease approved by US FDA under accelerated approval pathway. There are very few treatments available for treatment of Alzheimer’s disease, people affected with Alzheimer’s disease are not able to do daily tasks, and there is a risk of forgetting the way back to home when they go…
-
US FDA approves New Drug for Anemia due to chronic kidney disease
US FDA approves new drug Jesduvroq tablets which contain daprodustat for treatment of Anemia in Kidney disease patients on dialysis. First Orally taken drug approved for treatment of Anemia due to chronic kidney disease who is on dialysis for the past 4 months. There are medicines available for treatment of anemia caused by kidney disease…