Drug Approval | August 31, 2025
FDA suspends Valneva’s license of chikungunya vaccine IXCHIQ in US
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
Enters the high growth vitamins, minerals and supplements segment for adults, paediatrics, and animal health
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients
LHP588 is an oral, brain-penetrant lysine-gingipain (Kgp) inhibitor designed to block the key virulence factor of P. gingivalis
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Terufusion Advanced Infusion Systems combine a smart syringe pump, smart infusion pump, and pump monitoring system software for precise and efficient drug administration
The $700 million project is part of Roche’s $50 billion investment in US manufacturing, infrastructure and R&D
Guidelines aim to establish state-regulated veterinary blood banks
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