The scheme aims to avoid disruption in supply of critical active pharmaceutical ingredients (APIs) used to make critical drugs
Reblozyl is a standard of care for the first-line treatment of anemia without previous erythropoiesis stimulating agent use
It is intended for contrast enhancement in MRI scans
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
The submission is based on data from the STEP UP and STEP UP T2D clinical trials
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials
If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
This strategic move positions Sudeep Pharma to seamlessly integrate high-end premix capabilities with its mineral portfolio
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