Drug Approval | December 17, 2025
Lupin receives EIR from USFDA for Nagpur injectable facility
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion
The company operates a chain of mid-sized multi-speciality hospitals
The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
More than five drug candidates from his team progressed to human trials including drugs like Rilematovir (Phase IIb), and Bedaquiline
The innovation -- UPM Circular Renewable Black -- is the world’s first bio-based, near-infrared (NIR) detectable, carbon-negative black
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets
LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
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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