As a global mushroom biotechnology group, Mycelium Biotechnology is engaged in mushroom growing, global distribution and offering biotechnology and nutraceutical solutions through global partners
The announcement follows FDA 510(k) clearance of device
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
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 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 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
It is expanding the diagnostics business footprint in North East India
The plant is expected to start commercial operations from Q4FY24
The procedure, named 'Shetty Test' after its creator, could change the way suspected fractures are treated
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