Drug Approval | November 08, 2022
Zydus receives EIR with VAI from USFDA for Moraiya facility
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis
Innovative Capsugel Enprotect capsule can simplify the manufacturing process to accelerate drug development and expedite first-in-human timelines
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
Results reinforce commitment to next-generation oral SERD development programme
The award recognizes Parexel for delivering the best decentralized trial experience for customers through its capabilities, expertise, and patient recruitment and retention strategies
MoCD Type A is a rapidly progressive autosomal recessive inborn error of metabolism resulting in toxic sulfite levels causing neurologic sequelae
The TBDA is a collaboration established among biopharmaceutical companies, research organizations and universities to accelerate the discovery and development of novel therapeutic candidates against TB.
The move will add new global talent to Cytel’s Strategic Consulting group
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