The next step will be a site visit, UNC President Andy Feinstein said. The visit is expected to happen in October.
Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the ...
The endorsement of national medical associations’ guidance differs from previous years, when MDH would endorse the federal ...
The Food and Drug Administration said it is advising doctors to limit its use during pregnancy, despite countless medical organizations maintaining that the medication is safe for pregnant women.Many ...
The U.S. Food and Drug Administration has declined to approve a higher-dose version of Biogen's drug for a rare genetic disorder that causes progressive muscle weakness, dealing a setback to the ...