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
The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034
LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure
At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
Dr. Reddy's commits to achieving Net Zero greenhouse gas emissions across its value chain by FY 2045
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
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