Drug Approval | July 11, 2025
FDA accepts new drug application for Merck’s Doravirine/Islatravir
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
Lupin and Zentiva sign license and supply agreement for commercializing Certolizumab
The submission is based on data from the STEP UP and STEP UP T2D clinical trials
These medicines are essential in preventing RhD immunisation during pregnancy
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
SUP will obtain regulatory approvals for selling Tiotropium DPI in China
If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference
This strategic move positions Sudeep Pharma to seamlessly integrate high-end premix capabilities with its mineral portfolio
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
The company expects meaningful revenue contribution from this long-term agreement
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