EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
The validations confirm the completion of the applications and commence the scientific review process
The validations confirm the completion of the applications and commence the scientific review process
Acquisition of exclusive commercialization rights for European markets
Contributing to lower risk of potentially carcinogenic nitrosamine impurities in pharmaceuticals
Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA
VELSIPITY is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 years of age or older in the EU
Developed by Pfizer, Abrocitinib has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in India
Exblifeb demonstrates remarkable efficacy in treating complicated Urinary Tract Infections (cUTI), pneumonia
Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
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