Drug Approval | May 01, 2022
USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis
The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases
The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases
Onshore manufacturing facility is expected to be based in Quebec and produce up to 100 million mRNA respiratory vaccine doses annually
The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients
Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo
Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks
First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients
Business EPS of €1.94, up 20.5% on a reported basis and 16.1% at CER, also benefitting from an improved effective tax rate
Revenue from operations up 15% to Rs. 758 crore in fourth quarter
The approval by the DCGI comes following recommendations by the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation(CDSCO)
The approval comes soon after Corbevax was given the nod for 12-15-year group
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