News | June 26, 2025
Philogen withdraws marketing authorization application for Nidlegy in EU
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
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
The company was awarded the insulins supply contract for a three-year period in 2022 through April 2025
Fluralaner invented by Nissan Chemical is the active pharmaceutical ingredient of BRAVECTO and EXZOLT,
The supply of these goods is set to commence within the first quarter of FY26
The IND application supports the next phase of development of SBO-154
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