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
This action makes Veklury the first approved Covid-19 treatment for children less than 12 years of age
The tablets are available in 100 mg strength in bottle count sizes of 60
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