Results from the DELIVER and DAPA-HF Phase III trials demonstrate Dapagliflozin’ efficacy in heart failure regardless of ejection fraction
The European Commission granted CMA in December 2021 for use of Nuvaxovid in individuals aged 18 and over, and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in March 2022
Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date
If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of carbidopa/levodopa prodrugs
Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series
AKS-452 is currently undergoing Phase II/III clinical testing in India as a primary vaccine; submission for Emergency Use Authorization (EUA) expected by Q3 2022
The treatment of chorea associated with HD is within the scope of this Orphan Drug Designation
Pfizer to commercialize NURTEC ODT (rimegepant), an innovative compound for the prevention and acute treatment of migraine, a condition with high unmet need
If granted, Nuvaxovid would be the first protein-based Covid-19 vaccine option for adolescents in Australia and New Zealand
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
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