If granted, Nuvaxovid would be the first protein-based Covid-19 vaccine option for adolescents in Australia and New Zealand
The production suspension impacts commercial and clinical trial supply
The FDA has determined that the known and potential benefits of the vaccine for the prevention of Covid-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved vaccines are not accessible
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
CLNK is a biotechnology research and development company that utilizes umbilical cord blood as the raw material to develop innovative, allogeneic, off-the-shelf, cell based therapeutic products
The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients
In the trial, there was no statistical difference in estimated hypoglycaemia rates, and no severe hypoglycaemia events were observed for people treated with insulin icodec
Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks
Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children
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