by admin | Dec 2, 2019 | FDA
Y-mAbs Therapeutics, a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, announced that it has submitted to the U.S. Food and Drug Administration...
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 | Nov 11, 2019 | FDA
The Food and Drug Administration has given the go-ahead to what it calls the first next-generation sequencing test for detecting mutations that enable the most common strain of HIV to become immune to drugs. The FDA said that it had authorized marketing of...
by admin | Nov 4, 2019 | FDA
US-based medical device company Impulse Dynamics has secured the US FDA Supplemental-PMA approval for its next-generation, two-lead Optimizer Smart System intended for the treatment of heart failure. Impulse Dynamics has designed the Optimizer Smart System as 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...
