In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
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Intuitive receives FDA clearance for non-force feedback instruments in cardiac procedures
Intuitive CEO Dave Rosa highlighted that the clearance related to “several cardiac” procedures for non-force instruments used ...
Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...
According to Leadoptik's FDA application, the LIA catheter is an OCT-guided biopsy needle designed for use with endobronchial ...
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
Intuitive Surgical receives FDA clearance for the da Vinci 5 robot to be used in cardiac procedures, reports 18% procedure ...
April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...
The Food and Drug Administration (FDA) has approved Breyanzi ® (lisocabtagene maraleucel; liso-cel) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) ...
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