The FDA has determined that the known and potential benefits of the vaccine for the prevention of Covid-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved vaccines are not accessible
According to the National Institutes of Health, more than six million Americans, most age 65 or older, may have dementia caused by Alzheimer's disease, a brain disorder known to slowly destroy memory and thinking skills
Infigratinib is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any other indication
The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023
The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases
The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients
Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children
Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo
First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients
Star Array's focus has been on the development of an automated (cassette-based) nucleic acid purification system coupled with its superfast nucleic acid amplification technology
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