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
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
Move brings together AstraZeneca and Alexion colleagues in a purpose-built facility in Kendall Square, Cambridge, MA, a world-leading life sciences hub
Funds will be allocated to accelerate rapid production and high-end curation of whole genome sequences for its clinical application
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
It affects up to 10 per cent of women of reproductive age around the world
Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks
Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo
Glenmark Pharmaceuticals won Innovation of the Year award
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