by admin | Nov 25, 2019 | FDA
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for risdiplam, an investigational survival motor neuron-2 (SMN-2) splicing modifier for spinal...
by admin | Nov 25, 2019 | FDA
Usona Institute has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for psilocybin in the treatmentof major depressive disorder (MDD). Breakthrough Therapy Designation establishes FDA’s organizational commitment to promoting an...
by admin | Sep 26, 2019 | FDA
A vaccine developed by the Danish company Bavarian Nordic has received FDA approval to prevent infections by monkeypox, as well as protect against the threat of a smallpox bioterror attack. This approval makes Bavarian Nordic’s vaccine the only approved vaccine in the...
by admin | Sep 6, 2019 | FDA
Prescient Metabiomics has received FDA breakthrough status for its non-invasive colorectal cancer test. The test, called LifeKit Prevent, identifies microbial DNA and RNA biomarkers associated with the new, abnormal growth of tissue in the gastrointestinal tract. By...
