Drug Approval | December 20, 2025
Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
SandboxAQ will receive an upfront payment and could earn up to $200 million in milestone payments tied to preclinical, development, regulatory, and commercial achievements
Hansoh Pharma will receive an upfront payment in the low double-digit millions
India plays a critical role in Bristol Myers Squibb’s global strategy
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The FDA aims to make a decision by April 8, 2026
LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
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