Biopharma | December 16, 2025
FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
The inspection concluded with one minor observation in Form 483
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The company will respond to the US FDA within the stipulated timelines
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines
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