FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy
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 muscular
FDA grants Breakthrough Therapy Designation to psilocybin program for major depressive disorder
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 efficient development program for psilocybin in
Danish Smallpox Vaccine Gets FDA Approval to Fight Bioterrorism
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
Prescient gets FDA breakthrough status for colorectal cancer test
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 detecting these changes