Drug Approval | December 12, 2025
Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma
The FDA aims to make a decision by April 8, 2026
The FDA aims to make a decision by April 8, 2026
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 approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
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
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
Captured microbes are then neutralized on engineered microbicidal surfaces
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