FusionEdge Solutions, a joint venture between REI Systems and TechSur Solutions, has been awarded a $16 million contract to support the U.S. Food and Drug Administration's (FDA) Unified Registration ...
On March 9, the U.S. Food and Drug Administration (FDA) released a draft guidance document describing the agency’s perspective on premarket ...
A stronger version of the popular weight loss drug Wegovy is on the way after federal regulators signed off on a higher dose.
March 20 (Reuters) - The U.S. Food and Drug Administration said on Friday it has notified manufacturers of certain ...
March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce ...
FDA launches new AI-powered system to track drug and vaccine side effects in real time, replacing outdated databases and saving $120 million annually.
This marks the first dedicated transcatheter heart valve approved for high-risk patients with symptomatic severe AR.
The Food and Drug Administration's embattled vaccine chief, Dr. Vinay Prasad, is once again leaving the agency — the second ...
Opdivo (nivolumab) has received approvals for two new indications in classical Hodgkin Lymphoma (cHL) from the US Food and ...
Orphan designation reflects unmet need in RP rather than evidence of efficacy, while offering development incentives and ...
WASHINGTON (AP) — The Food and Drug Administration’s embattled vaccine chief, Dr. Vinay Prasad, is once again leaving the agency — the second time in less than a year that he’s departed after ...