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 announcement follows FDA 510(k) clearance of device
Three RFPs now open for qualified researchers through NORD's Jayne Holtzer rare disease research grants program
Avacc 3 has significant advantages over existing whooping cough vaccines
ABDM is a critical integration that leverages an open, interoperable, standards-based digital system that is secure, and maintains confidentiality and privacy of health-related personal information
The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases
Move brings together AstraZeneca and Alexion colleagues in a purpose-built facility in Kendall Square, Cambridge, MA, a world-leading life sciences hub
The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients
Funds will be allocated to accelerate rapid production and high-end curation of whole genome sequences for its clinical application
Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo
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