Drug Approval | August 23, 2024
Wanbury receives EIR from FDA for Patalganga facility
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
The fresh funds will be used to enhance customer relationships, expand operations and develop state-of-the-art service
Observes no adverse impact of non-nutritive sweetener (NNS) - sucralose on glycemic markers
CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced
ALS is a rare, progressive and fatal neurodegenerative disease, with an average life expectancy of 3 to 5 years from the time of symptom onset
FDA has concluded that this inspection is 'closed'
Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor discovered at Zydus
Operations of Line II was stopped due to a fire incident earlier
This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
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