Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...
Colorado lawmakers have advanced a bill that would allow a form of psilocybin to be prescribed as a medication if the federal government authorizes its use. About a week after the legislation was ...
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
1d
GRAFAPEX™ (treosulfan) for injection is approved by the FDA for sale and use in the United States only and is not intended for export outside the United States. Medexus makes no representation that ...
It's one of many steps for the company as it builds the infrastructure for what "will change medicine everywhere in the world ...
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